ZYNRELEF for Pain Management

Overseen By Julianne Sefko

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Washington University School of Medicine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine if local intra-operative application of ZYNRELEF (topical medication) during shoulder replacement surgery improves pain control (as defined by opioid consumption after surgery) compared to the use of an interscalene block with catheter. This is a randomized clinical trial without blinding. Subjects will complete patient reported outcomes before and after surgery. Subjects will track their narcotic use, pain scores and pain satisfaction after surgery.

Who Is on the Research Team?

Alexander Aleem, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals undergoing total shoulder replacement who need pain management. Participants must be able to report their pain levels and narcotic use after surgery. Specific inclusion and exclusion criteria are not listed, but typically involve factors like age, general health status, and absence of conditions that could interfere with the study.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for a total shoulder replacement surgery.

Exclusion Criteria

Active Workman's compensation claim

BMI > 40

I cannot have a specific type of pain relief catheter placed.

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Zynrelef

Trial Overview The study compares ZYNRELEF (a topical medication) applied during surgery to an interscalene block with catheter for post-surgery pain control. It measures which method leads to less opioid use after surgery. Patients' experiences with pain and satisfaction will also be tracked without blinding.

How Is the Trial Designed?

Group I: ZYNRELEF Active Control 1 Intervention

Group II: Interscalene block with continuous catheter pump Active Control 1 Intervention

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+