An interventional study of Liposomal Bupivacaine + Compound Betamethasone Injection and Compound Betamethasone Injection in Rotator Cuff Injuries and Adhesions, sponsored by Second Affiliated Hospital of Nanchang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Second Affiliated Hospital of Nanchang University · Not applicable, Interventional, and Treatment
Background: Patients undergoing arthroscopic surgery for rotator cuff tears with shoulder adhesion often experience significant postoperative pain and stiffness. This study investigates whether adding a long-acting local anesthetic (Liposomal Bupivacaine) to a standard anti-inflammatory steroid injection (Compound Betamethasone) during surgery can improve outcomes.
Methods: This is a prospective, randomized, double-blind, controlled trial. Approximately 70 eligible adult patients will be randomly assigned to one of two groups: (1) the Combination Group, receiving an intra-articular injection of Liposomal Bupivacaine plus Compound Betamethasone after surgery, or (2) the Control Group, receiving Compound Betamethasone alone. Patients and outcome assessors will not know the group assignment.
What participants will do: All participants will receive standard arthroscopic rotator cuff repair and adhesion release. They will be followed for 12 months after surgery, with assessments at multiple time points (from hours to months post-op) to measure pain levels, shoulder function, range of motion, and tendon healing via MRI.
Main Goals: The primary goal is to compare the improvement in UCLA shoulder scores between the two groups at 12 months. Secondary goals include comparing pain scores, other functional scores (Constant-Murley), joint mobility, MRI findings, and safety (complication rates).
Study Design: A prospective, randomized, double-blind, parallel-group, active-controlled clinical trial conducted at The Second Affiliated Hospital of Nanchang University.
Participants \& Sample Size: 70 patients (35 per group) with full-thickness rotator cuff tear and concomitant shoulder adhesion scheduled for arthroscopic repair. Sample size was calculated based on an expected difference in UCLA scores with 80% power and α=0.05, accounting for a 20% dropout rate.
Interventions:
Combination Therapy Group: After standard arthroscopic rotator cuff repair and capsular release, the shoulder joint will be injected with a mixture of Liposomal Bupivacaine and Compound Betamethasone under direct visualization.
Active Control Group: After the same surgical procedure, the joint will be injected with Compound Betamethasone alone.
Outcome Measures:
Primary: UCLA Shoulder Score (assessed pre-op, 3, 6, 12 months).
Secondary: Visual Analog Scale (VAS) for pain (assessed at 11 time points from pre-op to 12 months), Constant-Murley Shoulder Score, active range of motion (forward flexion, abduction), MRI evaluation of tendon healing using Signal-to-Noise Quotient (SNQ) of the supraspinatus tendon (distal and proximal), and incidence of complications (infection, re-tear, thrombosis, adhesion) within 12 months.
Statistics: Data will be analyzed using SPSS. Continuous variables will be compared using t-tests or non-parametric tests as appropriate. Categorical variables will be compared using Chi-square tests. A p-value \<0.05 will be considered statistically significant.
Ethics \& Registration: The study protocol will be submitted for approval to the Institutional Review Board of The Second Affiliated Hospital of Nanchang University. It will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. This trial is registered on ClinicalTrials.gov.
Funding: Supported by the Internal Grant Program of The Second Affiliated Hospital of Nanchang University.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Second Affiliated Hospital of Nanchang University is the lead sponsor of 85 studies on the registry; 52 are open to participants now.
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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 .
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Liposomal Bupivacaine combined with Compound Betamethasone.
Drug: Liposomal Bupivacaine + Compound Betamethasone Injection
Participants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Compound Betamethasone alone.
Drug: Compound Betamethasone Injection
Intra-articular injection of a mixture containing Liposomal Bupivacaine and Compound Betamethasone under arthroscopic guidance after standard surgical procedures.
Intra-articular injection of Compound Betamethasone alone under arthroscopic guidance after standard surgical procedures.
Change in Constant-Murley Shoulder Score
The Constant-Murley score is a composite outcome measure assessing shoulder pain, activities of daily living, range of motion, and strength. Scores range from 0 to 100, with higher scores indicating better function.
Time frame: Baseline, 3 months, and 12 months postoperatively.
Visual Analog Scale (VAS) Pain Score at Rest
Pain intensity at rest measured on a 100-mm Visual Analog Scale, where 0 mm represents "no pain" and 100 mm represents "worst pain imaginable."
Time frame: Baseline, 3 months, and 12 months postoperatively.
Active Range of Motion (ROM)
Measured in degrees for shoulder forward flexion, abduction, and external rotation using a goniometer
Time frame: Baseline, 3 months, and 12 months postoperatively.
American Shoulder and Elbow Surgeons (ASES) Score
A patient-reported outcome measure assessing pain and functional activities. Scores range from 0 to 100, with higher scores indicating better function.
Time frame: Baseline, 3 months, and 12 months postoperatively.
MRI Assessment of Tendon Healing
MRI Assessment of Tendon Healing
Time frame: 3 months and 12 months postoperatively.
Incidence of Treatment-Related Adverse Events
Number and severity of adverse events (e.g., infection, allergic reaction, abnormal bleeding, systemic effects) assessed as related to the study interventions (PRP and/or betamethasone injection).
Time frame: From the time of surgery up to 12 months postoperatively.
Plan to share: No
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Second Affiliated Hospital of Nanchang University