Postoperative Analgesia in Laparoscopic Abdominal Surgery After Exparel Via TAP or Local Infiltration

April 23, 2019 updated by: Alan Chang, University of Washington

On Postoperative Analgesic Requirements in Laparoscopic Colorectal Surgery Patients After Exparel Administration Via Transversus Abdominis Plane Block Versus Surgical Infiltration

This study evaluates differences in how administering liposomal bupivacaine via two different methods affects postoperative pain control in laparoscopic abdominal surgery patients. Half the participants will receive liposomal bupivacaine via a transverses abdominis plane block while the other half will receive liposomal bupivacaine via local infiltration.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Liposomal bupivacaine is a newer formulation of a local anesthetic that is commonly used for local infiltration, peripheral nerve blocks, and neuraxial anesthesia. This new formulation allows the effects of bupivacaine to last up to 72 hours as it is slowly released from a liposome. It is FDA approved for local infiltration and has recently been approved for interscalene blocks.

A transversus abdominis plane block is a fascial plane block that is performed routinely for postoperative pain relief for some abdominal incisions. It is performed by placing local anesthetic between the internal oblique and transverses abdominis muscle planes where it will provide analgesia to several dermatomes of the abdomen in hopes of improving postoperative pain relief and reducing postoperative opioid requirement.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Alan Chang, MD
  • Phone Number: 714-878-0850
  • Email: achang5@uw.edu

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:

  • Patients scheduled for elective laparoscopic colorectal surgery at UWMC requiring inpatient stay

Exclusion Criteria:

  • Patients on chronic pain mediations equaling or exceeding > 25 morphine daily equivalents
  • Patients allergic to bupivacaine
  • Patients with ASA status IV, V, or VI
  • Patients unable to consent
  • Patients that are pregnant
  • Patients that are incarcerated
  • Patients receiving procedures in addition to laparoscopic colorectal procedure
  • Patients on systemic anticoagulation precluding them from regional blocks

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Local infiltration
Liposomal bupivacaine (266mg) will be directly infiltrated by the surgeon into the surgical laparoscopic wound sites.
Drug: Exparel 266 MG Per 20 ML Injection
Liposomal bupivacaine
Experimental: Transversus abdominis plane block
Liposomal bupivacaine (266mg) will be used in a ultrasound guided transversus abdominis plane block.
Drug: Exparel 266 MG Per 20 ML Injection
Liposomal bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour post operative opioid consumption
Time Frame: 24 hours postoperative
Listed in morphine daily equivalents.
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12 hour post operative opioid consumption
Time Frame: 12 hours postoperative
Listed in morphine daily equivalents
12 hours postoperative
48 hour post operative opioid consumption
Time Frame: 48 hours postoperative
Listed in morphine daily equivalents
48 hours postoperative
Pain intensity at 12 hours post operative
Time Frame: 12 hours
Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)
12 hours
Pain intensity at 24 hours post operative
Time Frame: 24 hours
Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)
24 hours
Hospital length of stay
Time Frame: Until end of hospital stay, typically 3 days
How long the patient requires their inpatient stay measured in days.
Until end of hospital stay, typically 3 days

Collaborators and Investigators

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

Sponsor

University of Washington

Investigators

  • Principal Investigator: Vanessa Loland, MD, University of Washington

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)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007182

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We are not planning on making IPD available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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