Exparel for Rotator Cuff Surgery

Recruiting in Palo Alto (17 mi)

Overseen byCatherine J Fedorka, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: The Cooper Health System

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Catherine J Fedorka, MD

Principal Investigator

The Cooper Health System

Eligibility Criteria

This trial is for adults over 18 who are having rotator cuff surgery and will receive an interscalene block. It's not for those unwilling to have this block, pregnant or nursing women, people with liver disease or severe lung conditions like COPD, or allergies to bupivacaine or liposomal bupivacaine.

Inclusion Criteria

I am over 18 years old.

I am having shoulder surgery with a specific type of anesthesia.

Exclusion Criteria

I have a liver condition.

I do not want to have an interscalene block procedure.

I have COPD or other lung problems that prevent certain anesthesia methods.

See 2 more

Treatment Details

Interventions

Bupivacaine (Local Anesthetic)
Liposomal Bupivacaine (Local Anesthetic)

Trial OverviewThe study compares pain control and opioid use after rotator cuff surgery between two groups: one receiving a standard nerve block with bupivacaine alone, and the other getting a mix of liposomal bupivacaine plus regular bupivacaine. Participants are randomly assigned to either group.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Study- ExparelExperimental Treatment1 Intervention

patients will receive an interscalene block with Exparel solution, which is an extended-release formulation of bupivacaine consisting of 10cc liposomal bupivacaine mixed with 15cc bupivacaine. This is approved and used at the study institution

Group II: Control- Bupivacaine AloneActive Control1 Intervention

patients will receive a standard interscalene block with bupivacaine alone (25 cc of bupivacaine)