ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty

NCT07280195 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 202509174
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Shoulder Arthroplasty; Pain Management

Keywords

ZYNRELEF; Total shoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

• Narcotic consumption

  Narcotic consumption measured in morphine equivalent units (MEU)

  From surgery to two-weeks following surgery

Secondary Outcomes (2)

• Pain management cost

  Perioperative

• Pain management administration

  Perioperative

Study Arms (2)

ZYNRELEF

ACTIVE COMPARATOR

Drug: Zynrelef

Interscalene block with continuous catheter pump

ACTIVE COMPARATOR

Drug: Bupivacaine

Interventions

Zynrelef DRUG

ZYNRELEF

ZYNRELEF

Bupivacaine DRUG

Interscalene block with continuous catheter pump

Interscalene block with continuous catheter pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

bupivacaine-meloxicam drug combination; Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Alexander Aleem, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 12, 2025
• Study Start: February 14, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)