Abstract
BackgroundOptimal postoperative pain management is important to ensure patient comfort and early mobilization.MethodsIn this double-blind, placebo- and active-controlled, randomized clinical trial, we evaluated postoperative pain following knee replacement in patients receiving placebo, etoricoxib (90 or 120 mg), or ibuprofen 1800 mg daily for 7 days. Patients ≥18 years of age who had pain at rest ≥5 (0–10 Numerical Rating Scale [NRS]) after unilateral total knee replacement were randomly assigned to placebo (N = 98), etoricoxib 90 mg (N = 224), etoricoxib 120 mg (N = 230), or ibuprofen 1800 mg (N = 224) postoperatively. Co-primary endpoints included Average Pain Intensity Difference at Rest over Days 1–3 (0- to 10-point NRS) and Average Total Daily Dose of Morphine over Days 1–3. Pain upon movement was evaluated using Average Pain Intensity Difference upon Knee Flexion (0- to 10-point NRS). The primary objective was to demonstrate analgesic superiority for the etoricoxib doses vs. placebo; the secondary objective was to demonstrate that the analgesic effect of the etoricoxib doses was non-inferior to ibuprofen. Adverse experiences (AEs) including opioid-related AEs were evaluated.ResultsThe least squares (LS) mean (95% CI) differences from placebo for Pain Intensity Difference at Rest over Days 1–3 were -0.54 (-0.95, -0.14); -0.49 (-0.89, -0.08); and -0.45 (-0.85, -0.04) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.05 for etoricoxib vs. placebo). Differences in LS Geometric Mean Ratio morphine use over Days 1–3 from placebo were 0.66 (0.54, 0.82); 0.69 (0.56, 0.85); and 0.66 (0.53, 0.81) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.001 for etoricoxib vs. placebo). Differences in LS Mean Pain Intensity upon Knee Flexion were -0.37 (-0.85, 0.11); -0.46 (-0.94, 0.01); and -0.42 (-0.90, 0.06) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively. Opioid-related AEs occurred in 41.8%, 34.7%, 36.5%, and 36.3% of patients on placebo, etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively.ConclusionsPostoperative use of etoricoxib 90 and 120 mg in patients undergoing total knee replacement is both superior to placebo and non-inferior to ibuprofen in reducing pain at rest and also reduces opioid (morphine) consumption.Clinical trial registrationNCT00820027
Highlights
Optimal postoperative pain management is important to ensure patient comfort and early mobilization
Total knee replacement surgery is an option taken by patients who suffer from debilitating pain and loss of function, in association with demonstrated loss of cartilage due to a variety of conditions, but most commonly associated with osteoarthritis
The present study evaluates the use of etoricoxib, a selective COX-2 inhibitor, as part of a multimodal analgesic treatment in total knee replacement surgery patients
Summary
Optimal postoperative pain management is important to ensure patient comfort and early mobilization. The procedure has established efficacy and provides pain relief as well as functional improvement [1,2,3]. After the initial immediate postoperative period, good pain management improves quality of life and satisfaction with the procedure [6]. Nonsteroidal anti-inflammatory drugs (NSAIDs) provide good complementary effects for pain relief when combined with opioids in multimodal analgesia regimens, guidelines and common practice generally recommend patients discontinue them. These recommendations are due to the inhibition of cyclo-oxygenase (COX)-1 by traditional NSAIDs, which has been shown to interfere with platelet aggregation and can lead to the possibility of increased bleeding in surgical settings
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