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New painkiller aims to cut opioid use after shoulder surgery

NCT ID NCT07280195

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a medication applied directly during shoulder replacement surgery (ZYNRELEF) can reduce the need for strong painkillers after the operation, compared to the standard method of using a nerve block with a catheter. About 86 adults having shoulder replacement will be randomly assigned to one of the two pain management approaches. Researchers will track how much opioid medication each group uses, their pain scores, and satisfaction with pain control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 86 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Washington University

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.