Back to resultsComparison of Bupivacaine and Exparel for Carpal Tunnel Release
Primary Purpose
Pain After Carpal Tunnel Release
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Exparel
Sponsored by
About this trial
This is an interventional treatment trial for Pain After Carpal Tunnel Release
Eligibility Criteria
Inclusion Criteria:
- Patients with carpal tunnel syndrome undergoing surgery
Exclusion Criteria:
- Non english speaking
- Allergy to bupivacaine or exparel
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Bupivacaine
Exparel
Arm Description
Patients will received 0.5% Bupivacaine subcutaneously for local anesthesia during surgery
Patients will received Exparel subcutaneously for local anesthesia during surgery
Outcomes
Primary Outcome Measures
Pain
Pain will be evaluated using an 11-point ordinal scale (0-10)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02141178
Brief Title
Comparison of Bupivacaine and Exparel for Carpal Tunnel Release
Official Title
Does Long-Acting Liposomal Bupivacaine Provide Improved Pain Relief Over Bupivicaine Alone in Carpal Tunnel Release?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No IRB approval
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain After Carpal Tunnel Release
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Patients will received 0.5% Bupivacaine subcutaneously for local anesthesia during surgery
Arm Title
Exparel
Arm Type
Experimental
Arm Description
Patients will received Exparel subcutaneously for local anesthesia during surgery
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Exparel
Primary Outcome Measure Information:
Title
Pain
Description
Pain will be evaluated using an 11-point ordinal scale (0-10)
Time Frame
Starting immediately after surgery and then every 8 hours for 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with carpal tunnel syndrome undergoing surgery
Exclusion Criteria:
Non english speaking
Allergy to bupivacaine or exparel
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Bupivacaine and Exparel for Carpal Tunnel Release
We'll reach out to this number within 24 hrs