Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07280195

ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Total Shoulder Arthroplasty Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Zynrelef

Drug

ZYNRELEF

Bupivacaine

Drug

Interscalene block with continuous catheter pump

Primary outcomes

  1. Narcotic consumption

    Time frame: From surgery to two-weeks following surgery

    Narcotic consumption measured in morphine equivalent units (MEU)

Secondary outcomes

  1. 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

  2. Pain management administration

    Time frame: Perioperative

    Time needed by the anesthesiologists to perform the blocks in both groups.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.