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

Completed · Phase 4

Conditions studied: Bariatric Surgery Candidate, Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT03196505

Run by

University of California, San Francisco

People needed

231

Starts

2017-12-04

Expected to finish

2019-07-31

Last updated by the study team

2020-11-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All patients undergoing elective laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass surgeries.
• Fulfills NIH criteria for bariatric surgery

You may not qualify if…

• 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
• Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
• Patients requiring opiate use within 30 days prior to time of surgery.
• Patients with reported use of narcotics greater than 2 weeks in preceding year before surgery.
• Patients with history of substance abuse, alcohol addiction
• Patients with diagnosis of chronic pain, history of fibromyalgia, chronic regional pain syndrome (dystrophic pain syndrome).
• Bupivacaine use within 96 hours before operation
• Prisoners
• Bariatric surgery operation >3 hours.
• More than 5 laparoscopic incision sites used during surgery, conversion to open operation, placement of a feeding tube or drain.
• Patients with renal failure or hepatic failure.

Where it is running

• Fresno Heart and Surgical Hospital — Fresno, California, United States

Full record on ClinicalTrials.gov

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