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Exparel for Rotator Cuff Surgery

Phase 4
Waitlist Available
Led By Catherine J Fedorka, MD
Research Sponsored by The Cooper Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing rotator cuff surgery or shoulder arthroscopy using an interscalene block
Be older than 18 years old
Must not have
Patients unwilling to have interscalene block performed
Patients with preexisting chronic obstructive pulmonary disease (COPD) or respiratory issues precluding the use of an interscalene block
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every day for the first 2 weeks, and a one-time survey at the 6 week and 12 week visit.
Awards & highlights

Study Summary

This trial will investigate if a specific nerve block helps reduce pain after rotator cuff surgery.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, nausea, vomiting, dizziness, headache, fever; rare but serious effects could be heart problems, seizures or allergic reactions due to components in the injectable solutions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having shoulder surgery with a specific type of anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not want to have an interscalene block procedure.
Select...
I have COPD or other lung problems that prevent certain anesthesia methods.
Select...
I am currently pregnant or nursing an infant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every day for the first 2 weeks, and a one-time survey at the 6 week and 12 week visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and every day for the first 2 weeks, and a one-time survey at the 6 week and 12 week visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Use of pain medications
Secondary outcome measures
Pain severity

Trial Design

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)

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor
79 Previous Clinical Trials
35,233 Total Patients Enrolled
Catherine J Fedorka, MDPrincipal InvestigatorThe Cooper Health System
3 Previous Clinical Trials
250 Total Patients Enrolled
~27 spots leftby Jun 2025
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