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).
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Liposomal Bupivacaine + Compound Betamethasone Injection
DrugIntra-articular injection of a mixture containing Liposomal Bupivacaine and Compound Betamethasone under arthroscopic guidance after standard surgical procedures.
Compound Betamethasone Injection
DrugIntra-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.
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."
Active Range of Motion (ROM)
Measured in degrees for shoulder forward flexion, abduction, and external rotation using a goniometer
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.
MRI Assessment of Tendon Healing
MRI Assessment of Tendon Healing
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).
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