Coronary Artery Disease Clinical Trial
Official title:
Postoperative Analgesia After Cardiac Surgery - A Double-Blind, Prospective and Randomized Comparison of Wound Infiltration With Liposomal Bupivacaine and Bupivacaine Hydrochloride
Verified date | August 2021 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration
Status | Completed |
Enrollment | 60 |
Est. completion date | February 25, 2020 |
Est. primary completion date | December 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass) - Surgery with the use of cardiopulmonary bypass Exclusion Criteria: - Minimally invasive heart surgery through thoracotomy approach - Patient undergoing procedures under deep hypothermic circulatory arrest - Patients with active infections such as infective endocarditis - Emergency surgery - Patients undergoing transplantations and ventricular assist device insertion - Patients on any mechanical circulatory support preoperatively - Patient's refusal - End stage liver or renal disease - Allergy to bupivacaine - Patient who cannot understand the study procedure or refuse to participate - Redo-sternotomy - Participation in another study - Patients with severe right or left ventricular dysfunction (EF< 25%) - Patients requiring chronic opioids for chronic pain condition |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Kathirvel Subramaniam | Pacira Pharmaceuticals, Inc |
United States,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Delirium | Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC) | Assessment will be administered at 48 hours post-operatively | |
Other | Delirium | Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC) | Assessment will be administered at 72 hours post-operatively | |
Other | Patient Satisfaction | Patient will give an assessment regarding pain management on a scale of 0 - 10 with 0 indicating the lowest satisfaction with pain management and 10 indicating the highest satisfaction with pain management | Given at the time of discharge up to 30 days post-operatively | |
Other | Chronic Pain Assessment | Subjects will be asked the two following questions: "Are you currently experiencing pain?" as well as "Are you experiencing moderate to severe pain?" with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable. | 6 months after surgery | |
Other | Chronic Pain Assessment | Subjects will be asked the two following questions: "Are you currently experiencing pain?" as well as "Are you experiencing moderate to severe pain?" with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable. | 12 months after surgery | |
Other | Serum Cortisol Levels | Stress response suppression as a result of treatment will be evaluated by comparing hormone levels between the groups. Serum cortisol levels will be taken to measure this. | Measured 8, 48, and 72 hours post-operatively | |
Primary | Post-operative Pain Intensity | Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement | NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively | |
Primary | Total Narcotic Consumption | All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups. | 0-72 hours post-operative period | |
Secondary | Time to Extubation | The time it takes until the patient is extubated post-operatively will be measured | From the end of surgery until the patient is extubated up to 72 hours post-operatively | |
Secondary | Patient Time to Mobilization | The time it takes until patient ambulates will be measured | From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours* | |
Secondary | Patient Time to Out of Bed to Chair | The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured | From time of end of surgery to time of mobilization up to 72 hours post-operatively | |
Secondary | Patient Time to Oral Intake | The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured | From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge | |
Secondary | Non-invasive Ventilation (NIV) Requirement | Episodes of NIV such as upper airway masks or similar devices will be quantified | From time of end of surgery to 72 hours post-operatively or until hospital discharge | |
Secondary | Re-intubation | Instances of re-intubation will be recorded | From time of end of surgery to patient discharge up to one week | |
Secondary | Use of Incentive Spirometry | Frequency of incentive spirometry will be measured | From time of end of surgery to 72 hours post-operatively | |
Secondary | Post-operative Nausea and Vomiting | Whether a patient experiences at least one episode of nausea and emesis will be measured | From time of end of surgery to 72 hours post-operatively | |
Secondary | Major Organ Dysfunction | Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted | From date of surgery assessed up to 30 day post-operatively | |
Secondary | Length of Hospital and ICU Stay | Length of both hospital and ICU stay will be measured | From date of surgery assessed up to 30 day post-operatively | |
Secondary | Hospital Readmission | Readmission to hospital will be noted | From end of surgery assessed up to 30 days post-operatively | |
Secondary | Mortality | Mortality will be noted at specific timepoints | From end of surgery assessed up to 30 days post-operatively |
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