Comparison of Bupivacaine and Exparel for Carpal Tunnel Release

January 4, 2016 updated by: University of Pittsburgh

Does Long-Acting Liposomal Bupivacaine Provide Improved Pain Relief Over Bupivicaine Alone in Carpal Tunnel Release?

Carpal tunnel syndrome is one of the most common surgeries performed per year in the United States, accounting for over 600,000 surgeries. The procedure is commonly performed under light sedation and local anesthesia. Bupivicaine, a long acting local anesthetic, has been used to allow extended pain relief for 8-10 hours after carpal tunnel release. Exparel, a liposomal bupivicaine formulation, has been documented to provide pain relief for up to 72 hours post-operatively. By decreasing post-operative pain through the use of a long-acting local anesthetic, the use of narcotic pain medications may be decreased and patient satisfaction scores may increase.

The purpose of this study is to prospectively compare bupivicaine and liposomal bupivicaine with respect to post-operative pain control, narcotic usage, and patient satisfaction after carpal tunnel release.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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 Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

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 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with carpal tunnel syndrome undergoing surgery

Exclusion Criteria:

  • Non english speaking
  • Allergy to bupivacaine or exparel

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine
Patients will received 0.5% Bupivacaine subcutaneously for local anesthesia during surgery
Drug: Bupivacaine
Experimental: Exparel
Patients will received Exparel subcutaneously for local anesthesia during surgery
Drug: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Starting immediately after surgery and then every 8 hours for 10 days
Pain will be evaluated using an 11-point ordinal scale (0-10)
Starting immediately after surgery and then every 8 hours for 10 days

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

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

May 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 19, 2014

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO14040418

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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