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New combo injection aims to ease pain after rotator cuff surgery

NCT ID NCT07348016

Symptom relief Sponsor: Second Affiliated Hospital of Nanchang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a long-acting painkiller (liposomal bupivacaine) to a standard steroid injection during shoulder surgery can improve recovery for people with rotator cuff tears and shoulder stiffness. About 70 adults will be randomly assigned to receive either the combo or the steroid alone. Researchers will track pain, shoulder function, and healing over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Liposomal Bupivacaine and Compound Betamethasone injection
What this could lead to
If it works, this could lead to a simple way to reduce pain and improve shoulder function after rotator cuff surgery, helping patients recover faster.
What could go wrong
This is a small, early-phase trial with only 70 participants, so results may not apply to everyone. The added drug may not provide significant benefit over the standard steroid alone.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

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

Started

Aug 2025

Expected to finish

Dec 2028

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 to 70 years

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: Age between 18 and 70 years. Clinical and MRI diagnosis of full-thickness rotator cuff tear. Presence of shoulder stiffness/adhesion defined as passive range of motion less than 100° in forward flexion and/or less than 10° in external rotation (or according to your specific definition). Scheduled for arthroscopic rotator cuff repair and capsular release. Willing and able to provide written informed consent. Willing to comply with all study procedures and follow-up visits. Exclusion Criteria : Massive, irreparable rotator cuff tear. Severe glenohumeral osteoarthritis (Grade III or IV according to Samilson-Prieto classification). History of shoulder infection, fracture, or previous surgery on the affected shoulder. Known allergy or contraindication to betamethasone, local anesthetics, or components of PRP preparation. Systemic inflammatory arthritis (e.g., rheumatoid arthritis). Coagulation disorders or use of anticoagulants that cannot be safely suspended perioperatively. Pregnancy or lactation. Participation in another clinical trial within the past 3 months. Any medical or psychiatric condition that, in the investigator's opinion, would compromise patient safety or compliance with the study protocol.

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Conditions

The condition(s) this trial relates to.

frozen shoulder Rotator Cuff Injuries rotator cuff syndrome Tissue Adhesions

As listed by the trial registrant

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

Adhesions Rotator cuff injuries

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  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

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

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