Non-small Cell Lung Cancer Clinical Trial
Official title:
Effect of a Perioperative Opioid Free Anaesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response and Immunomodulation in Elective VATS Lobectomy for NSCLC Lung Cancer: A Prospective Randomized Study
Lobectomy is a major, high-risk surgical procedure that in addition to one-lung ventilation (OLV) exerts a potent surgical stress response. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis. The effect of anesthesia on the immune system is modest, compared to the effects induced by major surgery. However, to an immunocompromised patient, due to cancer and/or other comorbidities, the immunosuppressive effects of anesthesia may increase the incidence of post-operative infections, morbidity, and mortality. Exogenous opioids have been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes. An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological 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, will lead to an attenuated surgical stress response and attenuated immunosuppression, compared to a conventional Opioid-Based Anaesthesia-Analgesia (OBA-A) strategy. The aforementioned effects, are presumed to be associated with equal or improved analgesia and decreased incidence of postoperative infections compared to a perioperative OBA-A technique.
| Status | Recruiting |
| Enrollment | 70 |
| Est. completion date | November 1, 2026 |
| Est. primary completion date | November 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - patients undergoing elective VATS lobectomy - early stage NSCLC (up to T3N1M0) Exclusion Criteria: - Immunocompromised patients - previous lung surgery - preoperative corticosteroid or immunosuppressive drug use - uncontrolled Diabetes Mellitus - cardiac failure (NYHA 3 and 4) - preoperative infection (CRP >5mg/ml, WBC >10x10^9/L) - preoperative anemia (Hb<12g/dl) - chronic inflammatory diseases - inflammatory bowel disease Group-specific exclusion criteria: - OFA-?: perioperative opioid administration, within the study period - OBA-?: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period |
| Country | Name | City | State |
|---|---|---|---|
| Greece | University of Crete | Heraklion | Crete |
| Lead Sponsor | Collaborator |
|---|---|
| University of Crete |
Greece,
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* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Neutrophil to Lymphocyte ratio (NLR) | Neutrophil to Lymphocyte ratio (NLR) is a prognostic index that predicts patients' overall survival. Higher NLR has been correlated with worse outcome. | Preoperatively | |
| Primary | Platelet to Lymphocyte ratio (PLR) | Platelet to Lymphocyte ratio (PLR) is a prognostic index that predicts patients' overall survival. Higher PLR has been correlated with worse outcome. | Preoperatively | |
| Primary | Lymphocyte to monocyte ratio (LMR) | Lymphocyte to monocyte ratio (LMR) is a prognostic index that predicts patients' overall survival. Lower LMR has been correlated with worse outcome. | Preoperatively | |
| Primary | Advanced Lung Cancer Inflammation Index (ALI) | Advanced Lung Cancer Inflammation Index (ALI) is a prognostic index that predicts patients' recurrence-free survival and overall survival. ALI is calculated as (BMI x Alb / NLR) where BMI = body mass index, Alb = serum albumin, NLR (neutrophil lymphocyte ratio, a marker of systemic inflammation). Higher ALI scores have been correlated with worse outcome. | Preoperatively | |
| Primary | Systemic Immune Inflammation Index (SII) | Systemic Immune Inflammation Index (SII) is a prognostic index that predicts patients' overall survival. SII is calculated as follows: SII = platelet count × neutrophil/lymphocyte count. Higher SII scores have been correlated with worse outcome. | Preoperatively | |
| Primary | Prognostic Nutritional Index (PNI) | Prognostic Nutritional Index (PNI) is a prognostic index that predicts patients' overall survival. PNI is calculated as follows: PNI = 10 × serum albumin value (g/dL) + 0.005 × total lymphocyte count (per mm3) in the peripheral blood. Higher PNI scores have been correlated with worse outcome. | Preoperatively | |
| 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 | Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - IL-6 - end of surgery | Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups | End of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - IL-6 - 24 hours after the end of surgery | Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups | 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient) | |
| 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 | Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - IL-8 - end of surgery | Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups | End of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - IL-8 - 24 hours after the end of surgery | Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups | 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient) | |
| 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 | Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - IL-10 - end of surgery | Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups | End of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - IL-10 - 24 hours after the end of surgery | Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups | 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient) | |
| 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 | Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - TNF-a - end of surgery | Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups | End of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - TNF-a - 24 hours after the end of surgery | Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups | 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient) | |
| 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 | Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - CRP - end of surgery | Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups | End of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - CRP - 24 hours after the end of surgery | Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups | 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient) | |
| 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 | Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - WBC - end of surgery | Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups | End of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - WBC - 24 hours after the end of surgery | Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups | 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient) | |
| 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 | Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - AVP - end of surgery | Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups | End of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - AVP - 24 hours after the end of surgery | Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups | 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient) | |
| 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 | Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - cortisol - end of surgery | Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups | End of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - cortisol - 24 hours after the end of surgery | Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups | 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - HIF-1a- preoperatively | Inflammatory response and stress response as quantified by HIF-1a serum levels. Blood sample collection will take place in both study groups | Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - HIF-1a - end of surgery | Inflammatory response and stress response as quantified by HIF-1a serum levels. Blood sample collection will take place in both study groups | End of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - HIF-1a - 24 hours after the end of surgery | Inflammatory response and stress response as quantified by HIF-1a serum levels. Blood sample collection will take place in both study groups | 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - VEGF- preoperatively | Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups | Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - VEGF- end of surgery | Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups | End of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - VEGF - 24 hours after the end of surgery | Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups | 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - NF-?B - preoperatively | Inflammatory response and stress response as quantified by NF-?B serum levels. Blood sample collection will take place in both study groups | Preoperatively (as a baseline) | |
| Primary | Surgical Stress Response - NF-?B - end of surgery | Inflammatory response and stress response as quantified by NF-?B serum levels. Blood sample collection will take place in both study groups | End of surgery (end of placement of last suture/ surgical clip on patient) | |
| Primary | Surgical Stress Response - NF-?B - 24 hours after the end of surgery | Inflammatory response and stress response as quantified by NF-?B serum levels. Blood sample collection will take place in both study groups | 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient) | |
| 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 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. Standard Deviation 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 - 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 - Mean SBP | Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. 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 - SBP. 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 - SBP. 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 - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation 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 - 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 - 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. Standard Deviation 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 - 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 - 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. Standard Deviation 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 - 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 - 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. Standard Deviation 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 - 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. Standard Deviation 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 - 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. Standard Deviation 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 - 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. Standard Deviation 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 - 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. Standard Deviation 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 - Tachycardia | Intraoperative Tachycardia (defined as PR= 100 bpm), with episodes lasting =1 minute. Data will be reported in total seconds of intraoperative tachycardia. | Intraoperatively, assessed up to 4 hours. | |
| Primary | Haemodynamic Stability - Bradycardia | Intraoperative Bradycardia (defined as PR= 60 bpm), with episodes lasting =1 minute. Data will be reported in total seconds of intraoperative bradycardia. | Intraoperatively, assessed up to 4 hours. | |
| Primary | Haemodynamic Stability - Hypotension | Intraoperative Hypotension (defined as SBP=100mmHg or =70% 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. | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Hypertension | Intraoperative Hypertension (defined as SBP =130% 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. | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystalloid Fluid Requirements. | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements. | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated Red Blood Cell unit Requirements. | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements. | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements. | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Blood Loss - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Fluid Balance - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements | Intraoperatively, assessed up to 6 hours. | |
| Primary | Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively | Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements | Intraoperatively, assessed up to 6 hours. | |
| Secondary | Acute 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"). | Immediately postoperatively | |
| Secondary | Acute 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"). | First postoperative day | |
| Secondary | Acute 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"). | Second postoperative day | |
| Secondary | Acute 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"). | Third postoperative day | |
| Secondary | Acute 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). | Immediately postoperatively | |
| Secondary | Acute 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). | First postoperative day | |
| Secondary | Acute 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). | Second postoperative day | |
| Secondary | Acute 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). | Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - 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 Better" will be reported |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 "Effective, just about right" will be reported |
First postoperative day | |
| Secondary | Acute 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 "Effective, just about right" will be reported |
Second postoperative day | |
| Secondary | Acute 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 "Effective, just about right" will be reported |
Third postoperative day | |
| Secondary | Acute 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 that report "Would like to reduce medication" will be reported |
First postoperative day | |
| Secondary | Acute 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 that report "Would like to reduce medication" will be reported |
Second postoperative day | |
| Secondary | Acute 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 that report "Would like to reduce medication" will be reported |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
Third postoperative day | |
| Secondary | Acute 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 |
First postoperative day | |
| Secondary | Acute 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 |
Second postoperative day | |
| Secondary | Acute 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 |
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. | 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. | 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. | Third postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Aspiration Pneumonitis | Aspiration pneumonitis (defined as respiratory failure after the inhalation of regurgitated gastric contents) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Moderate respiratory failure | Moderate respiratory failure (SpO2 < 90% or PaO2 < 60 mmHg for 10 min in room air, responding to oxygen > 2 L/min) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Severe respiratory failure | Severe respiratory failure (need for non-invasive or invasive mechanical ventilation due to poor oxygenation) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - ARDS | Adult respiratory distress syndrome (mild, moderate, or severe according to the Berlin definition) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Pulmonary Infection | Pulmonary infection (defined as new or progressive radiographic infiltrate plus at least two of the following: antibiotic treatment, tympanic temperature > 38 °C, leukocytosis or leucopenia (white blood cell (WBC) count < 4000 cells/mm3 or > 12,000 cells/mm3) and/or purulent secretions) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Atelectasis | Atelectasis (suggested by lung opacification with shift of the mediastinum, hilum, or hemidiaphragm towards the affected area, and compensatory over-inflation in the adjacent non-atelectatic lung) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Cardiopulmonary edema | Cardiopulmonary edema (defined as clinical signs of congestion, including dyspnea, edema, rales, and jugular venous distention, with the chest x-ray demonstrating increase in vascular markings and diffuse alveolar interstitial infiltrates) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Pleural effusion | Pleural effusion (chest x-ray demonstrating blunting of the costophrenic angle, loss of the sharp silhouette of the ipsilateral hemidiaphragm in upright position, evidence of displacement of adjacent anatomical structures, or (in supine position) a hazy opacity in one hemithorax with preserved vascular shadows) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Pneumothorax | Pneumothorax (defined as air in the pleural space with no vascular bed surrounding the visceral pleura) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Pulmonary Infiltrates | Pulmonary infiltrates (chest x-ray demonstrating new monolateral or bilateral infiltrate without other clinical signs) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Prolonged air leakage | Prolonged air leakage (air leak requiring at least 7 days of postoperative chest tube drainage) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Purulent pleuritic | Purulent pleuritic (receiving antibiotics for a suspected infection, as far as not explained by the preoperative patient condition alone) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Pulmonary embolism | Pulmonary embolism (as documented by pulmonary arteriogram or autopsy, or supported by ventilation/perfusion radioisotope scans, or documented by echocardiography and receiving specific therapy) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Postoperative Pulmonary Complications - Lung hemorrhage | Lung hemorrhage (bleeding through the chest tubes requiring reoperation, or three or more red blood cell packs) | From the first postoperative day, until the fifth postoperative day | |
| Secondary | Chronic postoperative pain - Pain Detect | Evaluation of patients' pain using the standardized "Pain Detect" questionnaire. The "Pain Detect" questionnaire has been standardized for screening the presence of a neuropathic pain component. Patients will be interviewed by phone interview, 3 months after the end of surgery. The possible score a patient can have, ranges from 0 to 38. | Three months after the end of surgery |
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