Prospective randomized, double-blind, placebo-controlled study of pre- and post-operative 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 40mg administered pre- and post-operatively 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 40mg was administered orally as close as possible to 1h prior to the start of surgery. Each subsequent dose was administered at 24-h intervals up to 120h. 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 Anaesthesiology status, body mass index, incision length, and duration and types of operations. Mean PCA doses at 12 and 24h were 18.6 and 28.3mg in the study arm versus 26.2 and 41.2mg in controls, representing a one-third opioid reduction. Bowel sound and movement first appeared at medians of 12 and 72h in the study arm versus 24 and 84h, respectively, in controls (P<0.05). Tolerance of solid diet was at a median of 60h and discharge at a median of 4 days in the study arm versus 72h and 6 days in controls (P<0.05 and P<0.01, respectively). Seven (18%) morbidities occurred in the control versus six (15%) in the study arm.

Conclusion: 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. © 2007 Blackwell Publishing Ltd.