ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty

February 17, 2026 updated by: Alexander Aleem, Washington University School of Medicine
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult patients 18 years or older
  2. Indicated to undergo primary total shoulder arthroplasty (anatomic or reverse)

Exclusion Criteria:

  1. Any persons unable to consent, will not be eligible
  2. Patients undergoing revision arthroplasty or reverse shoulder arthroplasty
  3. Proximal humerus fractures
  4. Inability to have interscalene anesthetic catheter placement
  5. Compromised baseline renal function (CrCl < 50)
  6. BMI > 40
  7. History of GI bleed, prior duodenal surgery, or gastric sleeve resection
  8. Current narcotic use or prior consistent narcotic exposure in the last 6 months
  9. Use of perioperative oral steroid medications
  10. Active Workman's compensation claim
  11. Prior shoulder arthroplasty on the contralateral side in which an interscalene catheter was used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ZYNRELEF
Drug: Zynrelef
ZYNRELEF
Active Comparator: Interscalene block with continuous catheter pump
Drug: Bupivacaine
Interscalene block with continuous catheter pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic consumption
Time Frame: From surgery to two-weeks following surgery
Narcotic consumption measured in morphine equivalent units (MEU)
From surgery to two-weeks following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain management cost
Time Frame: Perioperative
Total cost of the interscalene single shot block plus Zynrelef compared to the cost of the block plus catheter with pain pump
Perioperative
Pain management administration
Time Frame: Perioperative
Time needed by the anesthesiologists to perform the blocks in both groups.
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Alexander Aleem, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202509174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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