NCT03196505

The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bariatric Surgery Candidate
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Exparel 266 MG Per 20 ML Injection	Liposomal bupivacaine 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).
DRUG	Bupivacaine	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).

Timeline

• Start date: 2017-12-04
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2017-06-22
• Last updated: 2020-11-25
• Results posted: 2020-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study