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

Pain, Postoperative Clinical Trial

— Exparel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196505
• Other study ID #: 2017061
• Status: Completed
• Phase: Phase 4
• Start date: December 4, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: November 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Pain, Postoperative

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Fresno Heart and Surgical Hospital	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & 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 ran — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Equivalents	in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.	within 1 week post-operatively
Secondary	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