ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty

NCT ID: NCT07280195

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Total Shoulder Arthroplasty Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZYNRELEF

Group Type ACTIVE_COMPARATOR

Zynrelef

Intervention Type DRUG

ZYNRELEF

Interscalene block with continuous catheter pump

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Interscalene block with continuous catheter pump

Interventions

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Zynrelef

ZYNRELEF

Intervention Type DRUG

Bupivacaine

Interscalene block with continuous catheter pump

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Alexander Aleem

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Aleem, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University

St Louis, Missouri, United States

Site Status

Countries

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United States

Central Contacts

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Julianne Sefko

Role: CONTACT

314-747-2496

Facility Contacts

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Julianne Sefko

Role: primary

314-747-2496

Other Identifiers

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202509174

Identifier Type: -

Identifier Source: org_study_id

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