Status:
TERMINATED
The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics
Lead Sponsor:
Andrews Research & Education Foundation
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
18-72 years
Phase:
PHASE4
Brief Summary
Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of this study. The purpose of this study is to determine if the product EXPAREL® can be used as a safe alternat...
Detailed Description
Based on prior research, it is hypothesized EXPAREL® can potentially be used as a local anesthetic option after undergoing an arthroscopic rotator cuff repair in the outpatient setting. Conducting thi...
Eligibility Criteria
Inclusion
- Male or female
- 18-72 years of age
- Subjects scheduled to undergo a rotator cuff repair with a subacromial decompression by one of the protocol investigators
Exclusion
- Planned concomitant glenoid labral repair
- Previous open shoulder surgery
- Neurological deficit or other disability involving the surgical extremity
- Anyone with a documented allergy to bupivicaine
- Subjects that are not mentally competent to give consent
- Pregnant women
- Subjects with an intolerance to hydrocodone or oxycodone and/or brand name equivalent combination medication
Key Trial Info
Start Date :
September 3 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03290196
Start Date
September 3 2015
End Date
April 7 2022
Last Update
March 30 2025
Active Locations (1)
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1
Andrews Research & Education Foundation
Gulf Breeze, Florida, United States, 32561