This study was performed (from September 2006 to March 2007) after institutional IRB approval. All TKA surgeries were performed by one surgeon (Ching-Chuan Jiang). Under a randomized, prospective, observer-blind study design, subjects were sorted by random numbers into two groups. Inclusion criteria for this study were primary osteoarthritis and an age over sixty. Exclusion criteria for this study were rheumatoid arthritis, end-stage renal disease (complete kidney dysfunction requiring dialysis or kidney transplantation), previous cerebral vascular accident history, peptic ulcers, recent myocardial infarction (within 1 year), and allergy to sulf, NSAIDs, or morphine. The National Taiwan University Hospital and National Institutes of Health have approved the study and all participants will provide written informed consent.
The study group (n = 40) received 400 mg oral celecoxib at about 1 hr prior to surgery, and 200 mg every 12 hrs, along with PCA morphine, over the first five post-operative days. The control group (n = 40) received PCA morphine over the same postoperative period.
All patients had spinal anesthesia and hemovac drain tubes inserted for postoperative blood loss evaluation. Patient data included gender, age, range of motion (ROM), pain scores, blood loss and procedure duration. Pain scores were measured using a visual analog scale (VAS), with 0 indicating no pain and 10 indicating the worst imaginable pain. Pain scores were checked by the same observer at rest at 6, 12, 24, 48 & 72 hrs and 7 days after TKA surgery. We encouraged patients to ambulate 24 hrs after TKA. Pain scores at ambulation were also analyzed. We measured the range of motion before ambulation by using a goniometer. Patients were supine on the bed and we identified bony landmarks, including the greater trochanter, lateral femoral condyle, and the lateral mallelous, to facilitate goniometer placement. All ranges of motion were measured preoperatively and postoperatively by the same study nurse (Lih-Ching Horng). The CPM machine was used twice a day in all patients. PCA morphine dose and PONV occurrence were also recorded. All NSAIDs were discontinued at seven days after surgery. All patients received a patient-controlled analgesia (PCA) pump after surgery. Morphine (1 mg/mL) was given intravenously with increases of 2 mL and a lockout interval of 10 minutes. Additionaly, thromboembolic prophlaxis (oral aspirin 100 mg) was given for seven postoperative days in both groups.
The primary endpoint was VAS pain reduction through perioperative celecoxib administration. Group sample sizes of 40 and 40 can achieve 85% power in the detection of a difference of one point on a 10-point VAS scale, which is equivalent to the minimal clinical significant difference on the VAS scale, in a design with four repeated measurements when the standard deviation is 1.8 points. Group sample sizes of 40 and 40 can achieve 91% power in the detection of a difference of one point for a 10-point VAS scale in a design with six repeated measurements, when the standard deviation is 1.8 points. Secondary endpoints include ROM, morphine-sparing effects, postoperative nausea, vomiting and blood loss.
Patient demographics were analyzed by ANOVA or Chi-squared test. Postoperative pain scores, postoperative ROM, morphine doses, blood loss, and PONV rates were analyzed by Mann-Whitney test. Group differences in pain intensity and ROM were also analyzed by repeated measures ANOVA test. Significance was defined as p < 0.05.
BMC Musculoskelet Disord © 2008 Huang et al; licensee BioMed Central Ltd.
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Cite this: Perioperative Celebrex Administration for Pain Management After Total Knee Arthroplasty — A Randomized, Controlled Study - Medscape - Jun 03, 2008.