Postoperative Pain Clinical Trial
Official title:
Effect of a Perioperative Opioid Free Anesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response in Elective Open Abdominal Aortic Aneurysm Repair: A Prospective Randomized Study
Open Abdominal Aortic Aneurysm (AAA) repair is a high-risk surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity/mortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international "opioid-crisis" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic/analgesic agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects. Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | October 8, 2027 |
| Est. primary completion date | October 8, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 85 Years |
| Eligibility | Inclusion Criteria: 1. Patient Consent 2. Age between 40 and 85 years old 3. Patients undergoing Elective Open Abdominal Aortic Infrarenal Aneurysm Repair Exclusion Criteria: 1. Immunocompromised patients 2. Patients with active infection 3. Reoperation on the aorta 4. Inflammatory bowel Disease 5. Malignancy 6. Chronic Inflammatory conditions (e.g. Rheymatoid arthritis, Psoriatic arthritis) 7. Chronic corticosteroid or immunosuppressive drug use |
| Country | Name | City | State |
|---|---|---|---|
| Greece | University of Crete | Heraklion | Crete |
| Lead Sponsor | Collaborator |
|---|---|
| University of Crete | University Hospital of Crete |
Greece,
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* Note: There are 21 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Surgical Stress Response - IL-6 - Preoperatively | Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups. | 1) Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - IL-6 - 15 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups. | 2) 15 minutes after aortic cross-clamping | |
| Primary | Surgical Stress Response - IL-6 - 60 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups. | 3) 60 minutes after aortic cross-clamp release | |
| Primary | Surgical Stress Response - IL-6 - 24 hours after aortic cross-clamp release | Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups. | 4) 24 hours after aortic cross-clamp release | |
| Primary | Surgical Stress Response - IL-8 - Preoperatively | Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups. | 1) Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - IL-8 - 15 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups. | 2) 15 minutes after aortic cross-clamping | |
| Primary | Surgical Stress Response - IL-8 - 60 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups. | 3) 60 minutes after aortic cross-clamp release | |
| Primary | Surgical Stress Response - IL-8 - 24 hours after aortic cross-clamp release | Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups. | 4) 24 hours after aortic cross-clamp release | |
| Primary | Surgical Stress Response - IL-10 - Preoperatively | Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups. | 1) Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - IL-10 - 15 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups. | 2) 15 minutes after aortic cross-clamping | |
| Primary | Surgical Stress Response - IL-10 - 60 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups. | 3) 60 minutes after aortic cross-clamp release | |
| Primary | Surgical Stress Response - IL-10 - 24 hours after aortic cross-clamp release | Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups. | 4) 24 hours after aortic cross-clamp release | |
| Primary | Surgical Stress Response - AVP - Preoperatively | Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups. | 1) Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - AVP - 15 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups. | 2) 15 minutes after aortic cross-clamping | |
| Primary | Surgical Stress Response - AVP - 60 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups. | 3) 60 minutes after aortic cross-clamp release | |
| Primary | Surgical Stress Response - AVP - 24 hours after aortic cross-clamp release | Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups. | 4) 24 hours after aortic cross-clamp release | |
| Primary | Surgical Stress Response - TNF-a - Preoperatively | Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups. | 1) Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - TNF-a - 15 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups. | 2) 15 minutes after aortic cross-clamping | |
| Primary | Surgical Stress Response - TNF-a - 60 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups. | 3) 60 minutes after aortic cross-clamp release | |
| Primary | Surgical Stress Response - TNF-a - 24 hours after aortic cross-clamp release | Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups. | 4) 24 hours after aortic cross-clamp release | |
| Primary | Surgical Stress Response - Cortisol - Preoperatively | Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups. | 1) Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - Cortisol - 15 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups. | 2) 15 minutes after aortic cross-clamping | |
| Primary | Surgical Stress Response - Cortisol - 60 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups. | 3) 60 minutes after aortic cross-clamp release | |
| Primary | Surgical Stress Response - Cortisol - 24 hours after aortic cross-clamp release | Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups. | 4) 24 hours after aortic cross-clamp release | |
| Primary | Surgical Stress Response - CRP - Preoperatively | Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups. | 1) Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - CRP - 15 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups. | 2) 15 minutes after aortic cross-clamping | |
| Primary | Surgical Stress Response - CRP - 60 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups. | 3) 60 minutes after aortic cross-clamp release | |
| Primary | Surgical Stress Response - CRP - 24 hours after aortic cross-clamp release | Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups. | 4) 24 hours after aortic cross-clamp release | |
| Primary | Surgical Stress Response - WBC - Preoperatively | Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups. | 1) Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - WBC - 15 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups. | 2) 15 minutes after aortic cross-clamping | |
| Primary | Surgical Stress Response - WBC - 60 minutes after aortic cross-clamp | Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups. | 3) 60 minutes after aortic cross-clamp release | |
| Primary | Surgical Stress Response - WBC - 24 hours after aortic cross-clamp release | Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups. | 4) 24 hours after aortic cross-clamp release | |
| Primary | Haemodynamic Stability - Mean PR | Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean PR will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Minimum PR | Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum PR values will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Maximum PR | Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum PR will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Standard Deviation PR | Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of the PR values will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - PR change induction | Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after anesthesia induction, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - PR change incision | Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after surgical incision, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - PR change clamp | Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamping, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - PR change clamp release 1 | Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - PR change clamp release 2 | Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - Mean SBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SBP will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Minimum SBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SBP will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Maximum SBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SBP will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Standard Deviation SBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SAP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SBP values will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - SBP change induction | Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after anesthesia induction, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - SBP change incision | Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after surgical incision, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - SBP change clamp | Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamping, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - SBP change clamp release 1 | Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - SBP change clamp release 2 | Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - Mean DBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean DBP will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Minimum DBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum DBP will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Maximum DBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum DBP will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Standard Deviation DBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of DBP values will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - DBP change induction | Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after anesthesia induction, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - DBP change incision | Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after surgical incision, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - DBP change clamp | Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamping, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - DBP change clamp release 1 | Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - DBP change clamp release 2 | Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - Mean MBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean MBP will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Minimum MBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum MBP will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Maximum MBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum MBP will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Standard Deviation MBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of MBP values will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - MBP change induction | Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after anesthesia induction, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - MBP change incision | Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after surgical incision, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - MBP change clamp | Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after aortic clamping, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamping, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - MBP change clamp release 1 | Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamp release of the first lower extremity, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - MBP change clamp release 2 | Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor. | 1 minute after aortic clamp release of the second lower extremity, compared to 1 minute prior | |
| Primary | Haemodynamic Stability - Mean CO | Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CO will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Minimum CO | Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CO will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Maximum CO | Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CO will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Standard Deviation CO | Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of CO values will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Mean CI | Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CI will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Minimum CI | Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CI will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Maximum CI | Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CI will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Standard Deviation CI | Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of CI values will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Mean SV | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SV will be reported for each patient, extracted from the collected data . | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Minimum SV | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SV will be reported for each patient, extracted from the collected data . | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Maximum SV | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SV will be reported for each patient, extracted from the collected data . | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Standard Deviation SV | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SV values will be reported for each patient, extracted from the collected data . | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Mean SVV | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVV will be reported for each patient, extracted from the collected data . | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Minimum SVV | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVV will be reported for each patient, extracted from the collected data . | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Maximum SVV | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVV will be reported for each patient, extracted from the collected data . | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Standard Deviation SVV | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SVV values will be reported for each patient, extracted from the collected data . | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Mean SVI | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVI will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Minimum SVI | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVI will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Maximum SVI | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVI will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Standard Deviation SVI | Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index- SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. The Standard Deviation of SVI values will be reported for each patient, extracted from the collected data. | Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours. | |
| Primary | Haemodynamic Stability - Tachycardia | Intraoperative Tachycardia (defined as PR= 100 bpm), with episodes lasting =1 minute. Data will be reported in total seconds of intraoperative tachycardia. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Bradycardia | Intraoperative Bradycardia (defined as PR= 40 bpm), with episodes lasting =1 minute. Data will be reported in total seconds of intraoperative bradycardia. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Hypotension | Intraoperative Hypotension (defined as SBP=90mmHg or =80% of preoperative Baseline), with episodes lasting =1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypotension. | Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Hypertension | Intraoperative Hypertension (defined as SBP =120% of preoperative Baseline), with episodes lasting =1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypertension. | Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements. Data will be reported in ml/kg*h. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Fluid requirements - Crystalloids - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystaloid Fluid Requirements. Data will be reported in ml/kg*h. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements. Data will be reported in ml/kg*h. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Fluid requirements - Colloids - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements. Data will be reported in ml/kg*h. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements. Data will be reported in ml. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Fluid requirements - Concentrated RBCs - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated RBC unit Requirements. Data will be reported in ml. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements. Data will be reported in ml. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Fluid requirements - Plasma - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements. Data will be reported in ml. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements. Data will be reported in ml. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Fluid requirements - Platelets - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements. Data will be reported in ml. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Blood Loss - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss. Data will be reported in ml. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Blood Loss - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss. Data will be reported in ml. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Fluid Balance - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance.
Data will be reported in ml. |
From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Fluid Balance - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance. Data will be reported in ml. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements. Data will be reported in mg. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Adrenaline - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements. Data will be reported in mg. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements. Data will be reported as an averaged rate in mcg/kg*min. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements. Data will be reported in mg. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Ephedrine - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements. Data will be reported in mg. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements.Data will be reported as an averaged rate in mcg/kg*min. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Dobutamine - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements. Data will be reported as an averaged rate in mcg/kg*min. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Dopamine - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements. Data will be reported as an averaged rate in mcg/kg*min. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements. Data will be reported as an averaged intraoperative rate in mcg/kg*min. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - 24 hours postoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements. Data will be reported as an averaged rate in mcg/kg*min. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Secondary | Postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively | Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). | 1) Immediately postoperatively (if awakened prior to ICU admission) | |
| Secondary | Postoperative pain - Numerical Rating Scale (NRS) - First postoperative day | Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). | 2) First postoperative day | |
| Secondary | Postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day | Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). | 3) Second postoperative day | |
| Secondary | Postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day | Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). | 4) Third postoperative day | |
| Secondary | Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Immediately Postoperatively | Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain). | 1) Immediately postoperatively (if awakened prior to ICU admission) | |
| Secondary | Postoperative pain - Critical Care Pain Observation Tool (CPOT) - First postoperative day | Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain). | 2) First postoperative day | |
| Secondary | Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Second postoperative day | Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain). | 3) Second postoperative day | |
| Secondary | Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Third postoperative day | Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain). | 4) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Intolerable" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Intolerable" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Intolerable" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Tolerable with discomfort" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Tolerable with discomfort" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Tolerable with discomfort" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Comfortably manageable" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Comfortably manageable" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Comfortably manageable" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Negligible Pain" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Negligible Pain" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
Intolerable Tolerable with discomfort Comfortably manageable Negligible Pain The percentage of patients that report pain that is "Negligible Pain" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
Getting worse About the same Getting better The percentage of patients that report pain that is "Getting worse" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
Getting worse About the same Getting better The percentage of patients that report pain that is "Getting worse" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
Getting worse About the same Getting better The percentage of patients that report pain that is "Getting worse" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
Getting worse About the same Getting better The percentage of patients that report pain that is "About the same" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
Getting worse About the same Getting better The percentage of patients that report pain that is "About the same" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
Getting worse About the same Getting better The percentage of patients that report pain that is "About the same" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
Getting worse About the same Getting better The percentage of patients that report pain that is "Getting better" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
Getting worse About the same Getting better The percentage of patients that report pain that is "Getting better" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
Getting worse About the same Getting better The percentage of patients that report pain that is "Getting better" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Inadequate pain control" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Inadequate pain control" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report "Inadequate pain control" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report pain control that is "Effective, just about right" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report pain control that is "Effective, just about right" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients that report pain control that is "Effective, just about right" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
Inadequate pain control Effective, just about right Would like to reduce medication The percentage of patients whose pain control is reported as "Would like to reduce medication" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
Can't do anything because of pain Pain keeps me from doing most of what I need to do Can do most things, but pain gets in the way of some Can do everything I need to do The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Awake with occasional pain" will be reported |
3) Third postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - First postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Normal sleep" will be reported |
1) First postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Second postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Normal sleep" will be reported |
2) Second postoperative day | |
| Secondary | Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Third postoperative day | Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
Awake with pain most of the night Awake with occasional pain Normal sleep The percentage of patients whose sleep is reported as "Normal sleep" will be reported |
3) Third postoperative day | |
| Secondary | Analgesic Requirements - First postoperative day | Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required. | 1) First postoperative day | |
| Secondary | Analgesic Requirements - Second postoperative day | Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required. | 2) Second postoperative day | |
| Secondary | Analgesic Requirements - Third postoperative day | Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required. | 3) Third postoperative day | |
| Secondary | Kidney function - Furosemide requirement - Intraoperatively | Kidney function as quantified by furosemide requirement to maintain urine output. Data will be reported in mg. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Secondary | Kidney function - Furosemide requirement - 24 hours postoperatively | Kidney function as quantified by furosemide requirement to maintain urine output. Data will be reported in mg. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Secondary | Kidney function - MDRD GFR - Preoperatively | Kidney function as assessed by preoperative GFR calculated by the MDRD GFR equation. | 1) Preoperatively (as a baseline) | |
| Secondary | Kidney function - MDRD GFR - Immediately postoperatively | Kidney function as assessed by postoperative GFR calculated by the MDRD GFR equation. | 2) At the end of surgery 1h after the end of placement of last suture/surgical clip on patient, upon ICU admission. | |
| Secondary | Kidney function - MDRD GFR - 24h Postoperatively | Kidney function as assessed by postoperative GFR calculated by the MDRD GFR equation. | 3) 24h postoperatively | |
| Secondary | Kidney function - Urine Output - Intraoperatively | Kidney function as quantified by urine output. Data will be reported as an averaged intraoperative rate in ml/kg*h. | From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours | |
| Secondary | Kidney function - Urine Output - 24 hours postoperatively | Kidney function as quantified by urine output. Data will be reported as an averaged rate in ml/kg*h. | From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively | |
| Secondary | Length of stay - ICU | All patients will spend at least 1 day in the ICU for postoperative monitoring. ICU length of stay will be reported in days. | From day of surgery until day of ICU stay. | |
| Secondary | Length of stay - Hospital Discharge | Hospital length of stay will be reported in days. | From day of surgery until hospital discharge |
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