A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair: A Prospective Randomized Comparison

Participants Selection After obtaining institutional review board approval and written informed consent from all participants, the investigators prospectively enrolled 180 participants scheduled to undergo arthroscopic acromioplasty and rotator cuff repair for a partial or full thickness tear between September 2011 and August 2012.

A priori statistical power analysis was performed to calculate the number of subjects required. A difference of one point in the visual analogue scale (VAS) was defined as the minimal clinically important difference. With a power of 80% and an alpha of 0.05, the power analysis demonstrated that a sample size of 51 participants per group was needed. Assuming a dropout rate of 20%, the investigators calculated a sample size of 60 participants per group.

Participants were randomly assigned in equal numbers to receive selective COX-2 inhibitors (celecoxib; Celebrex® 200 mg bid, Pfizer, Korea), traditional NSAIDs (ibuprofen; Carol-F® 385 mg tid, Ildong, Korea), or opioid drugs (tramadol; Tridol® 50 mg bid, Yuhan, Korea) for 2 weeks from the first day after surgery.

Analgesic medication was not prescribed preoperatively. Subacromial participant-controlled analgesia (Automed 3200, Ace Medical, Seoul, Korea) was used for the first 48 hours postoperatively in all participants. Intravenous cefazolin was used as the postoperative antibiotic for one day. If participants could not tolerate pain with regular postoperative medication, oxycodone (IR codon 5 mg, Unimed, Korea) was administered as rescue medication; the maximum dosage was limited to 20 mg per day according to the investigators institution's standard postoperative pain control procedures for 2 weeks after surgery.

Clinical and Radiological Assessment Participants rated pain and satisfaction with medication using a VAS of 0 (no pain/no satisfaction) to 10 (unbearable pain/extreme satisfaction) preoperatively and 3 days and 2 weeks postoperatively. Administration of rescue medication and side effects were also recorded. Side effects were categorized into five categories: nausea/vomiting, somnolence/dizziness, gastrointestinal complications (constipation, diarrhea, abdominal discomfort), pruritus, and bruising; respiratory difficulties, renal failure, heart failure, and seizure were also evaluated.