ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zynrelef, Bupivacaine.
- Who it may be relevant to
- Registry conditions: Total Shoulder Arthroplasty, Pain Management. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug Zynrelef
ZYNRELEF - Drug Bupivacaine
Interscalene block with continuous catheter pump
Primary outcome measures
- Narcotic consumption [Time frame: From surgery to two-weeks following surgery]
Secondary outcome measures (2)
- Pain management cost [Time frame: Perioperative]
- Pain management administration [Time frame: Perioperative]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Washington University — St Louis
Identifiers
NCT: NCT07280195 · 202509174