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

Primary Purpose

Bariatric Surgery Candidate, Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel 266 MG Per 20 ML Injection
Bupivacaine
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate focused on measuring Anesthetics, Local, Liposomal Bupivacaine, Bupivacaine, Postoperative Complications, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, Laparoscopic Bariatric Surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fresno Heart and Surgical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Liposomal Bupivacaine

Control

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 20, 2017
Last Updated
November 3, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03196505
Brief Title
The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery
Acronym
Exparel
Official Title
The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Pain, Postoperative
Keywords
Anesthetics, Local, Liposomal Bupivacaine, Bupivacaine, Postoperative Complications, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, Laparoscopic Bariatric Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liposomal Bupivacaine
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Exparel 266 MG Per 20 ML Injection
Other Intervention Name(s)
EXPAREL
Intervention Description
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
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
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 Measure Information:
Title
Morphine Equivalents
Description
in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.
Time Frame
within 1 week post-operatively
Secondary Outcome Measure Information:
Title
Cumulative Pain Score
Description
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.
Time Frame
within 48 hours post operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pearl Ma, MD
Organizational Affiliation
University of San Francisco - Fresno
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fresno Heart and Surgical Hospital
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31375443
Citation
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.
Results Reference
result

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

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