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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Bariatric Surgery Candidate
• Intervention / Treatment: Drug: Exparel 266 MG Per 20 ML Injection; Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Fresno Heart and Surgical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 <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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liposomal Bupivacaine; 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).	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).; Other Names: EXPAREL
Active Comparator: Control; 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).	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).; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Equivalents	in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.	within 1 week post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Pain Score	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.	within 48 hours post operatively

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Pearl Ma, MD, University of San Francisco - Fresno

Publications and helpful links

General Publications

• Ma P, Lloyd A, McGrath M, Shuchleib Cung A, Akusoba I, Jackson A, Swartz D, Boone K, Higa K. Efficacy of liposomal bupivacaine versus bupivacaine in port site injections on postoperative pain within enhanced recovery after bariatric surgery program: a randomized clinical trial. Surg Obes Relat Dis. 2019 Sep;15(9):1554-1562. doi: 10.1016/j.soard.2019.06.004. Epub 2019 Jun 17.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Bupivacaine; Liposomal Bupivacaine; Postoperative Complications; Anesthetics, Local; Sleeve Gastrectomy; Roux-en-Y Gastric Bypass; Laparoscopic Bariatric Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2017061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No