ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty

Phase 4Enrolling By InvitationNCT07280195

Washington University School of Medicine86 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Total Shoulder Arthroplasty Pain Management

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Narcotic consumption

Narcotic consumption measured in morphine equivalent units (MEU)

Time frame: From surgery to two-weeks following surgery

Secondary Outcomes

Pain management cost

Total cost of the interscalene single shot block plus Zynrelef compared to the cost of the block plus catheter with pain pump

Time frame: Perioperative

Pain management administration

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