Prospective randomized, double-blind, placebo-controlled study of pre- and postoperative administration of a COX-2-specific inhibitor as opioid-sparing analgesia in major colorectal surgery.

PURPOSE: To demonstrate the opioid-sparing effect and reduction in postoperative ileus obtained with valdecoxib 40 mg administered pre- and postoperatively in patients undergoing colorectal resection.
METHODS: Patients for elective colorectal resection from December 2002 to June 2004 were randomized to receive either valdecoxib or placebo with standard patient-controlled analgesia (PCA) morphine. In the study arm, the first dose of valdecoxib 40 mg was administered orally as close as possible to 1 h prior to the start of surgery. Each subsequent dose was administered at 24-h intervals up to 120 h. Patients in the control arm were served placebos at the same time-points.
RESULTS: Forty patients were enrolled in the study arm and 39 (excluding one protocol violation) in the control arm. The groups were comparable in age, sex, American Society of Anesthesiology status, body mass index, incision length, and duration and types of operations. Mean PCA doses at 12 and 24 h were 18.6 and 28.3 mg in the study arm vs 26.2 and 41.2 mg in controls, representing a one-third opioid reduction. Bowel sound and movement first appeared at medians of 12 and 72 h in the study arm vs 24 and 84 h, respectively, in controls (P < 0.05). Tolerance of solid diet was at a median of 60 h and discharge at a median of 4 days in the study arm vs 72 h and 6 days in controls (P < 0.05 and P < 0.01, respectively). Seven (18%) morbidities occurred in the control vs six (15%) in the study arm.
CONCLUSIONS: Patients treated with a cyclo-oxygenase 2-specific inhibitor have a shorter recovery time when compared with patients on a standard postoperative PCA morphine-only regimen after colorectal resection.

RCT Entities:   Population Interventions Outcomes