A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Selective cyclooxygenase (COX)-2 inhibitors are commonly used analgesics that provide similar
      analgesia but reduced adverse effects compared to other analgesics. However, few studies have
      been conducted on postoperative pain and tendon-to-bone healing. Here, the investigators
      investigated the effect of a selective COX-2 inhibitor on analgesia and tendon-to-bone
      healing following arthroscopic rotator cuff repair.
    

Detailed description: 
      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.

      Of the 180 participants, 82 were followed for at least 24 months after surgery. Shoulder
      functional scores were obtained based on range of motion (ROM) data, pain VAS scores,
      Constant-Murley Shoulder scores, American Shoulder and Elbow Surgeons scores, and Korean
      Shoulder Scoring system scores. Radiological integrity of the repaired rotator cuff was
      assessed using magnetic resonance imaging (MRI) in 70 participants (25 in the celecoxib
      group, 23 in the ibuprofen group, and 22 in the tramadol group) and ultrasonography in the
      remaining 12 participants . Postoperative rotator cuff integrity assessed using MRI was
      categorized as type I to V according to the classification developed by Sugaya et al. as
      follows: type I, sufficient thickness compared with the normal cuff and homogenously low
      intensity; type II, sufficient thickness compared with the normal cuff and partial high
      intensity; type III, insufficient thickness (less than half the thickness of the normal cuff)
      but no discontinuity, suggesting a partial-thickness delaminated tear; type IV, presence of a
      minor discontinuity in 1-2 slices on both oblique coronal and sagittal images, suggesting a
      small full-thickness tear; type V, presence of a major discontinuity in more than two slices
      on both oblique coronal and sagittal images, suggesting a medium or large full-thickness
      tear. Postoperative incomplete healing or re-tear was defined as either Sugaya type IV or V.

      MRI and ultrasonography data were analyzed by a musculoskeletal radiologist with 10 years of
      experience who was blinded to the study. The deltoid muscle, subacromial/subdeltoid bursa,
      long head of the biceps tendon, and entire rotator cuff were examined, with special emphasis
      on the integrity of the subscapularis tendon, supraspinatus tendon, infraspinatus tendon, and
      teres minor tendon. The tendons were scanned along their long and short axes. The radiologist
      defined a full-thickness tear as incomplete healing or a re-tear, such as a hypoechoic
      full-thickness cleft inside the tendon, detachment of the tendon from the bone, insertion
      with medial dislocation, and non-visualization of the tendon.

      Surgical Procedure and Postoperative Care The senior investigator conducted all surgical
      procedures arthroscopically using three portals: anterior, lateral, and posterior. In
      participants with a stiff shoulder, manipulation was performed with capsular release.
      Synovectomy, biceps procedures, and debridement for partially torn rotator cuff tendons were
      performed for the glenohumeral joint. After glenohumeral procedures, subacromial
      decompression was performed to remove inflamed bursal tissue, and acromioplasty was conducted
      with a motorized burr in almost all participants except those with an extremely thin acromion
      to yield a flat acromion undersurface and to ensure adequate working space for the repair.
      Distal clavicle resection was performed in selected participants. The anteroposterior and
      retraction size of the tear were measured with a calibrated probe, and footprint preparation
      was performed with a ring curette, rasp, and shaver to expose the bleeding bony surface.
      After anchors were inserted according to the selected repair technique, the loaded sutures
      were passed through the tendon using a flexible suture passer (Expressew®, Depuy Mitek,
      Raynham, MA) or a suture passer (Spectrum®, Linvatec, Largo, FL). All sutures were secured
      using the SMC knot. After subacromial procedures, the operator always returned to the
      glenohumeral joint for irrigation and to identify medial anchor pull-out, missed foreign
      materials, or biceps incorporated into rotator cuff repair.

      All participants followed the same rehabilitation protocol. They wore an abduction brace for
      5 weeks and started passive ROM after brace removal. Participants who had limited motion
      preoperatively started tolerable controlled passive motion right after pain had subsided
      postoperatively. Shrugging of the shoulder and active motion of the elbow (flexion,
      extension), forearm (supination, pronation), wrist, and hand were encouraged immediately
      after surgery. After brace weaning, active assisted ROM was performed according to a
      pre-established protocol for 6 weeks. After full passive ROM was obtained,
      muscle-strengthening exercises were started; all sports activities were permitted 6 months
      after surgery. All physical therapy protocols were followed with the cooperation and
      supervision of a rehabilitation physician.

      Statistical Analysis Statistical analysis was performed using SPSS software (version 18.0E;
      SPSS Inc., Chicago, IL). Frequency and descriptive statistics were analyzed to determine the
      baseline characteristics, and the t-test, chi-square test, analysis of variance, and
      Mann-Whitney test were performed to compare the three groups. Tukey's post-hoc test and
      Bonferroni's test were used to determine the groups between which differences occurred.
      Statistical significance was set at P < 0.05.
    

Intervention name(s): Celecoxib; Ibuprofen; Tramadol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 capsule of 200mg Celebrex PO(per oral) twice a day for 14 days; 1 tablet of 385mg Ibuprofen PO(per oral) twice a day for 14 days; 1 tablet of 50mg Tramadol PO(per oral) twice a day for 14 days
Other intervention name(s): Celebrex; Carol-F; Tridol
Intervention MeSH terms: Ibuprofen; Celecoxib; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment