Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-01-18 @ 5:57 PM
Study NCT ID:
NCT07280195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: