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Corticosteroid

Exparel vs Dexamethasone for Rotator Cuff Surgery Pain

Phase 4

Waitlist Available

Research Sponsored by Rothman Institute Orthopaedics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants having a primary rotator cuff repair

Age 18 and older

Must not have

Revision rotator cuff repair (RCR) cases

Participants having an open RCR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial focuses on finding safe and effective ways to manage pain after shoulder surgery, aiming to reduce reliance on opioid medications in light of the ongoing opioid epidemic in the United States."

Who is the study for?

This trial is for individuals with rotator cuff injuries who have undergone surgery. It's aimed at those seeking effective postoperative pain management without relying heavily on opioids, which can be addictive.

What is being tested?

The study is testing the effectiveness of two different medications for managing pain after shoulder surgery: Dexamethasone and Liposomal bupivacaine (Exparel), compared to a standard treatment using Bupivacaine Hcl.

What are the potential side effects?

Possible side effects may include discomfort or pain at the injection site, nausea, headache, dizziness, and potential allergic reactions. Long-term use of steroids like Dexamethasone could lead to more serious side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having or have had a primary repair of my rotator cuff.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having a second surgery on my rotator cuff.

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I have an open RCR.

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I have used opioids in the 3 months before my surgery.

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I have no allergies or medical reasons preventing me from taking the study medications.

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I need a graft to help repair my rotator cuff.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative narcotic medication use

Postoperative pain levels

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Group 1: Shoulder Block using ExparelActive Control2 Interventions

Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + bupivacaine given in their shoulder block before surgery.

Group II: Group 2: Shoulder Block using Exparel + DexamethasoneActive Control3 Interventions

Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery.

0 / 7Eligibility criteria met