The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery
Overview
- Phase
- Phase 4
- Intervention
- Exparel 266 MG Per 20 ML Injection
- Conditions
- Bariatric Surgery Candidate
- Sponsor
- University of California, San Francisco
- Enrollment
- 231
- Locations
- 1
- Primary Endpoint
- Morphine Equivalents
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing total IV and oral morphine equivalents required after laparoscopic bariatric surgery. Liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the course of three days. Having a long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5-hour half-life. In some studies, the use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery. This has not yet been studied in bariatric patients and the use of liposomal bupivacaine can potentially improve patient post-operative pain control, decrease narcotic use, decrease hospital length of stay and readmission rates and improve patient satisfaction after bariatric surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients undergoing elective laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass surgeries.
- •Fulfills NIH criteria for bariatric surgery
Exclusion Criteria
- •Patients deemed not a candidate for laparoscopic bariatric surgery
- •Patients with previous bariatric or gastric surgeries.
- •BMI \<35 and \> 60 kg/m2
- •Preoperative inability to ambulate and confined to wheelchair.
- •American Society of Anesthesiologist (ASA) score \>3
- •Concurrent ventral hernia repair or intraoperative extensive lysis of adhesions
- •Not able to understand informed consent, or unwilling to sign consent.
- •Not able to understand and read English
- •Currently pregnant or lactating.
- •Age \<18 or \>65
Arms & Interventions
Liposomal Bupivacaine
Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
Intervention: Exparel 266 MG Per 20 ML Injection
Control
60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Morphine Equivalents
Time Frame: within 1 week post-operatively
in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.
Secondary Outcomes
- Cumulative Pain Score(within 48 hours post operatively)