Phase 4 N=231 Randomized Quadruple-blind Treatment

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

Bariatric Surgery Candidate · Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT03196505 ↗

Enrolled (actual)

231

Serious AEs

4.5%

Results posted

Nov 2020

Primary outcome: Primary: Morphine Equivalents — 8.3; 7.5 MEU

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Exparel 266 MG Per 20 ML Injection (Drug); Bupivacaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Morphine Equivalents	8.3; 7.5	—
SECONDARY Cumulative Pain Score	3.5; 3.6	—

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.

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 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03196505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.