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

• Status: Enrolling by invitation
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cooper Health System
• Treatments: Bupivacaine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Patients above 18 years of age

• Undergoing rotator cuff surgery or shoulder arthroscopy using an interscalene block

Exclusion Criteria:

• Patients with preexisting chronic obstructive pulmonary disease (COPD) or respiratory issues precluding the use of an interscalene block

• Pregnant women, women nursing infants

• Patients with preexisting liver disease

• Patients unwilling to have interscalene block performed

• Patients allergic to bupivacaine, liposomal bupivacaine, or any ingredients contained within the two drugs listed