Clinical Trial

The Effect of Liposomal Bupivacaine Nerve Block (Exparel) in Rotator Cuff Surgery

Enrolling by Invitation Phase 4
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Summary
The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed with liposomal bupivacaine versus the standard treatment of bupivacaine alone. The main question aims to answer if patients who receive liposomal bupivacaine have better pain control and lower postoperative opioid consumption compared to bupivacaine alone. Participants be randomized to either the control group to receive a standard interscalene block with bupivacaine (25 cc of bupivacaine) or the experimental group to receive similar dosing of liposomal bupivacaine mixed with bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine). Data will be prospectively collected and the data from the experimental group will be compared to the control group at the completion of the study period.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-11-14.
Trial Details
NCT Number NCT06139666
Lead Sponsor The Cooper Health System
Conditions Rotator Cuff Tears, Postoperative Pain, Opioid Use
Enrollment 160 participants
Start Date 2019-07-11
Primary Completion 2024-06-01 (estimated)
Study Completion 2025-06-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-20