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Summary

for people ages 18–65 (full criteria)
healthy people welcome
at Fresno, California
study started
estimated completion:

Description

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.

Keywords

Bariatric Surgery Candidate Pain, Postoperative Anesthetics, Local Liposomal Bupivacaine Bupivacaine Postoperative Complications Roux-en-Y Gastric Bypass Sleeve Gastrectomy Laparoscopic Bariatric Surgery Anesthetics Narcotics

Eligibility

You can join if…

Open to people ages 18–65

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

You CAN'T join 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.

Location

  • Fresno Heart and Surgical Hospital not yet accepting patients
    Fresno, California, 93720, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03196505
Phase
Phase 4
Lead Scientist
Pearl Ma
Study Type
Interventional
Last Updated
October 24, 2017
I’m interested in this study!