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

NCT03196505 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2017061
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Pain, Postoperative

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Morphine Equivalents

  in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.

  within 1 week post-operatively

Secondary Outcomes (1)

• Cumulative Pain Score

  within 48 hours post operatively

Study Arms (2)

Liposomal Bupivacaine

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

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

Interventions

Exparel 266 MG Per 20 ML Injection DRUG

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).

Also known as: EXPAREL

Liposomal Bupivacaine

Bupivacaine DRUG

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).

Also known as: Marcaine

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Fresno Heart and Surgical Hospital

Fresno, California, 93720, United States

Location

Related Publications (1)

• 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.

  PMID: 31375443 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications

Interventions

Injections; Bupivacaine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Pearl Ma
• Organization: University of California-San Francisco Fresno

pma@fresno.ucsf.edu

5592614500

Study Officials

• Pearl Ma, MD

  University of San Francisco - Fresno

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: December 4, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: November 25, 2020
• Results First Posted: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)