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

Phase 4

Completed

• Conditions: Bariatric Surgery Candidate; Pain, Postoperative
• Interventions: Drug: Exparel 266 MG Per 20 ML Injection; Drug: Bupivacaine

• Registration Number: NCT03196505
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-22
• Study Start: 2017-12-04
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Results First Submitted: 2019-09-25
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Results First Posted: 2020-11-25
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

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

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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
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine	Exparel 266 MG Per 20 ML Injection	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).
Control	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).

Primary Outcome Measures

Name	Time	Method
Morphine Equivalents	within 1 week post-operatively	in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.

Secondary Outcome Measures

Name	Time	Method
Cumulative Pain Score	within 48 hours post operatively	Average pain scores by blinded nurse obtained. Analogue pain rating scale ranged from 0 to 10 with 0 being no pain and 10 being the worst possible pain. Assessment of pain and nausea were performed every 4 hours after operation until discharge.

Trial Locations

Locations (1)

Fresno Heart and Surgical Hospital; 🇺🇸 Fresno, California, United States