Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
- Conditions
- Coronary Artery StenosesValve Regurgitation, TricuspidCoronary Artery DiseaseValve Regurgitation, Mitral
- Interventions
- Registration Number
- NCT03270514
- Lead Sponsor
- Kathirvel Subramaniam
- Brief Summary
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
- Detailed Description
There are no studies to date on the use of LB infiltration and its analgesic efficacy in cardiac surgery done through sternotomy, even though the majority of cardiac surgeries utilize this approach. Moderate to severe pain is common in patients undergoing these surgeries and is usually inadequately treated. Other various pain treatment modalities such as opioid and neuraxial anesthesia are avoided due to potentially dangerous side effects in this cohort. The efficacy of local anesthesia techniques, such as bupivacaine, are limited due to short duration of action and increased incidence of wound infection. On the other hand, slow release liposomal bupivacaine may last up to 72 hours, indicating it's potential for more adequate analgesia compared to bupivacaine.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exparel Injectable Product Exparel Injectable Product Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30). Bupivacaine Hydrochloride Bupivacaine Hydrochloride Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
- Primary Outcome Measures
Name Time Method Post-operative Pain Intensity 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 Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement
Total Narcotic Consumption 0-72 hours post-operative period 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.
- Secondary Outcome Measures
Name Time Method Post-operative Nausea and Vomiting From time of end of surgery to 72 hours post-operatively Whether a patient experiences at least one episode of nausea and emesis will be measured
Non-invasive Ventilation (NIV) Requirement From time of end of surgery to 72 hours post-operatively or until hospital discharge Episodes of NIV such as upper airway masks or similar devices will be quantified
Use of Incentive Spirometry From time of end of surgery to 72 hours post-operatively Frequency of incentive spirometry will be measured
Major Organ Dysfunction From date of surgery assessed up to 30 day post-operatively 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
Time to Extubation From the end of surgery until the patient is extubated up to 72 hours post-operatively The time it takes until the patient is extubated post-operatively will be measured
Patient Time to Out of Bed to Chair From time of end of surgery to time of mobilization up to 72 hours post-operatively The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured
Patient Time to Oral Intake From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured
Re-intubation From time of end of surgery to patient discharge up to one week Instances of re-intubation will be recorded
Length of Hospital and ICU Stay From date of surgery assessed up to 30 day post-operatively Length of both hospital and ICU stay will be measured
Patient Time to Mobilization From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours* The time it takes until patient ambulates will be measured
Hospital Readmission From end of surgery assessed up to 30 days post-operatively Readmission to hospital will be noted
Mortality From end of surgery assessed up to 30 days post-operatively Mortality will be noted at specific timepoints
Trial Locations
- Locations (1)
UPMC Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States