Adding a long‑acting local anesthetic to a steroid injection after arthroscopic rotator cuff repair for shoulder adhesion

Safety and Efficacy of Platelet-Rich Plasma Combined With Compound Betamethasone in Arthroscopic Surgery for Rotator Cuff Injury With Shoulder Adhesion: A Prospective, Multicenter, Randomized Controlled Trial

We will test whether adding liposomal bupivacaine to a standard intra‑articular steroid injection helps adults having arthroscopic rotator cuff repair with shoulder adhesion have less pain and better shoulder function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Nanchang University (Academic / other)
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT07348016 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, double‑blind, parallel‑group trial enrolling about 70 adults with full‑thickness rotator cuff tear and shoulder adhesion undergoing arthroscopic repair and capsular release. Participants are randomized to receive either a combination injection of liposomal bupivacaine plus compound betamethasone or compound betamethasone alone into the joint at the end of surgery. Patients and outcome assessors are blinded, and follow‑up visits occur through 12 months with assessments at multiple time points. The primary outcome is the UCLA Shoulder Score, with secondary outcomes including VAS pain scores, Constant‑Murley score, active range of motion, MRI tendon healing (SNQ), and complication rates.

Who should consider this trial

Good fit: Adults aged 18–70 with MRI‑confirmed full‑thickness rotator cuff tear and concomitant shoulder adhesion who are scheduled for arthroscopic repair and capsular release and can consent and attend follow‑up are ideal candidates.

Not a fit: Patients with massive irreparable tears, severe glenohumeral osteoarthritis, prior shoulder infection or surgery on the affected side, allergies to the study drugs, systemic inflammatory arthritis, or bleeding disorders are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, the combination injection could reduce postoperative pain and stiffness and improve recovery of shoulder function after rotator cuff repair.

How similar studies have performed: Previous work on liposomal bupivacaine for postoperative shoulder pain has reported mixed results and combining intra‑articular steroids is common but not definitively proven for preventing adhesion‑related stiffness, so this specific combination is relatively novel.

Eligibility criteria

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.

Where this trial is running

Nanchang, Jiangxi

• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Study coordinator: Hao Liang, MD

Conditions Rotator Cuff Injuries; Adhesions; Platelet-Rich Plasma; Compound Betamethasone; Arthroscopy; Randomized Controlled Trial; Shoulder; Stiffness