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

NCT ID: NCT03196505

Last Updated: 2020-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2019-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Exparel 266 MG Per 20 ML Injection

Intervention Type: 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).

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).

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

EXPAREL; Marcaine

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 <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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pearl Ma, MD

Role: PRINCIPAL_INVESTIGATOR

University of San Francisco - Fresno

Locations

Fresno Heart and Surgical Hospital

Fresno, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 31375443 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017061

Identifier Type: -

Identifier Source: org_study_id