• Curr Med Res Opin · Aug 2012

    Randomized Controlled Trial Multicenter Study

    Perioperative use of etoricoxib reduces pain and opioid side-effects after total abdominal hysterectomy: a double-blind, randomized, placebo-controlled phase III study.

    • Eugene R Viscusi, Tara L Frenkl, Craig T Hartrick, Narinder Rawal, Henrik Kehlet, Dimitris Papanicolaou, Arnold Gammaitoni, Amy T Ko, Leslie M Morgan, Anish Mehta, Sean P Curtis, and Paul M Peloso.
    • Department of Anesthesiology, Thomas Jefferson University, Philadelphia, PA 19107, USA. Eugene.Viscusi@jefferson.edu
    • Curr Med Res Opin. 2012 Aug 1;28(8):1323-35.

    ObjectiveTo evaluate the effects of two different doses of etoricoxib delivered perioperatively compared with placebo and standard pain management on pain at rest, pain with mobilization, and use of additional morphine/opioids postoperatively.Research Design And MethodsIn this double-blind, placebo-controlled, randomized clinical trial, we evaluated postoperative pain following total abdominal hysterectomy over 5 days in patients receiving placebo or etoricoxib administered 90 min prior to surgery and continuing postoperatively. Patients were randomly assigned to receive either placebo (n = 144), etoricoxib 90 mg/day (n = 142), or etoricoxib 120 mg/day (n = 144). Average Pain Intensity at Rest over days 1-3 (0- to 10-point numerical rating scale [NRS]) was the primary efficacy endpoint. Secondary endpoints included Average Pain Intensity upon Sitting, Standing, and Walking over days 1-3 (0- to 10-point NRS) as well as Average Total Daily Dose of Morphine over days 1-3.Clinical Trial RegistrationThis trial is registered on www.clinicaltrials.gov (NCT00788710).ResultsThe least squares (LS) means (95% CI) for the primary endpoint were 3.26 (2.96, 3.55); 2.46 (2.16, 2.76); and 2.40 (2.11, 2.69) for placebo, etoricoxib 90 mg, and etoricoxib 120 mg, respectively, significantly different for both etoricoxib doses versus placebo (p < 0.001). Patients on etoricoxib 90 mg and 120 mg required ~30% less morphine per day than those on placebo (p < 0.001), which led to more rapid bowel recovery in the active treatment groups by ~10 hours vs. placebo. A greater proportion of patients on etoricoxib (10-30% greater than placebo) achieved mild levels of pain with movement, defined as pain ≤3/10.LimitationsA key limitation for this study was that movement-evoked pain measurements were not designated as primary endpoints.ConclusionIn patients undergoing total abdominal hysterectomy, etoricoxib 90 mg and 120 mg dosed preoperatively and then continued postoperatively significantly reduces both resting and movement-related pain, as well as reduced opioid (morphine) consumption that led to more rapid bowel recovery.

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