Use of Exparel for Postoperative Analgesia Following Bariatric Surgery

June 4, 2019 updated by: McMaster University

Use of Long-acting Local Analgesia in Bariatrics: A Randomized Controlled Trial

The aim of this study is to evaluate the efficacy of liposomal bupivicaine in post operative analgesia for patients undergoing bariatric surgery when compared to conventional local analgesia. Patients will be randomly selected to receive either liposomal bupivicaine or conventional bupivicaine via a transversus abdominal plane block during surgery. Patients will be followed post-operatively to assess use of narcotics, post-operative pain and nausea scores, and length of stay.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Optimizing pain management following bariatric surgery is an important aspect of patient care and post-surgical recovery. Despite advances in post-operative pain management, this remains a challenge and opioids continue to dominate as the most widely used analgesia for post-surgical pain management. Opioid use especially in the opioid-naive patient carries significant short term and long term risks including over dependence and chronic opioid use.

Movements towards minimizing post-operative opioid use has shown regional anesthetic techniques to be highly effective in the management of pain in surgical patients. More specifically, liposomal bupivicaine (Exparel) is a novel non-opioid local analgesia that takes advantage of a multi-vesicular liposomal system to provide extended analgesia release over 72-96 hours.

The purpose of this study to evaluate the use of liposomal bupivicaine in the management of post-operative pain following bariatric surgery via a transversus abdominis plane (TAP) block. Patients will be randomized to receiving either liposomal bupivicaine or traditional 0.25% bupivicaine locally infiltrated at the time of bariatric surgery. Both liposomal bupivicaine and traditional bupivicaine will be administered via TAP block after identification of planes via laparoscopy by the bariatric surgeon.

Patients will be followed post-operatively to assess use of opioid analgesia between the two arms. In addition, they will be assessed with respect to pain and nausea using analog scores, as well as hospital length of stay.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • The patient previously met NIH criteria for bariatric surgery and has not received a previous bariatric surgical procedure
  • The patient is aged 18-65 years and has completed the screening and preparation process prescribed by the Ontario Bariatric Network

Exclusion Criteria:

  • Inability to give informed consent
  • ASA > 4
  • Planned procedure other than Roux-en-Y gastric bypass (RYGB) or contraindications to RYGB
  • BMI > 55 kg/m2
  • Revisional procedure
  • Allergies or suspected allergies to local anesthetic medications (bupivicaine)
  • Renal insufficiency (GFR < 30ml/min)
  • History of chronic pain needing daily medications for the last >3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exparel (Liposomal Bupivicaine)
20 ml vial of liposomal bupivacaine containing 266 mg (maximum dose), will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.
Drug: Exparel 266 MG Per 20 ML Injection
266mg of liposomal bupivacaine 266 mg, 20 mL volume, will be diluted with 20 ml of 0.25% bupivacaine (50 mg of bupivacaine) and 20 ml saline, thereby totalling 60mL volume. Total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.
Active Comparator: 0.25% Bupivicaine HCL
Two 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes and levels via laparoscopy. Medication will be given just below the last rib and extend to below the lowest incision.
Drug: Bupivacaine Hcl 0.25% Inj
0.25% bupivacaine, 60mL total, divided into two 30mL syringes and delivered via TAP block on either side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of liposomal bupivicaine via TAP block in eliminating narcotic use post-operatively
Time Frame: 10 days
Proportion of patients requiring narcotics post-procedure until discharge as recorded via their electronic medical record.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analog pain scores
Time Frame: 10 days (or until discharge)
Pain will be assessed in the post-anaesthesia care unit (PACU) at 2 occasions - upon arrival and before transfer to ward. Subsequently, pain scores will then be reassessed at 8 am, 2 pm, and 8pm until discharge. Pain will be measured on an 11-point scale from 0 (no pain) to 10 (most pain imaginable) and the average of the PACU and ward scores will be used as the final outcomes.
10 days (or until discharge)
Post-operative nausea
Time Frame: 10 days (or until discharge)
Postoperative nausea scores will be assessed daily at 8 am, 2 pm, and 8pm until discharge using an 11-point scale from 0 (no nausea) to 10 (most nausea imaginable)
10 days (or until discharge)
Post-operative Narcotic Use
Time Frame: 10 days (or until discharge)
Postoperative narcotic use will be recorded in morphine equivalent units and recorded via their electronic medical record.
10 days (or until discharge)
Hospital Length of Stay
Time Frame: Total length of stay will be calculated from registration until discharge to home; usually spans 2-5 days.
Length of stay calculated in hours
Total length of stay will be calculated from registration until discharge to home; usually spans 2-5 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Pacira Pharmaceuticals, Inc

Investigators

  • Principal Investigator: Margherita Cadeddu, MD, FRCSC, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJHC80

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual participant data

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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