A randomized trial of the peri-operative use of COX-2 inhibitors in Lichtenstein herniorrhaphy

Introduction: We present a randomized controlled trial to evaluate the value of the cyclo-oxygenase-2 (COX-2) inhibitor, rofecoxib, as an adjuvant for pain management for patients undergoing a conventional Lichtenstein inguinal herniorrhaphy. The drug was removed from the market coincidentally with the conclusion of the trial due to thrombotic complications. We believe that the data remains important, however, because of the imminent release of similar compounds with a better safety profile. No industry support was sought or accepted for this trial, with the exception of the study drug and an identical placebo preparation supplied by Merck in a completely unrestricted agreement. Methods and materials: Seventy-nine patients were recruited for the single-center randomized controlled double blinded trial, with 27 receiving placebo, 26 who received rofecoxib only in the post-operative period, and 26 who received rofecoxib both in the pre- and post-operative period. The patients were followed for 6 weeks with serial administration of the short form 36 health survey questionnaire (SF-36), visual analog scale (VAS) questionnaire, and activity restriction questionnaire. Statistical analysis was performed using multivariate generalized estimating equations in a blinded fashion. Results: The mean pain over time decreased over the 6 weeks and was significantly lower in the group that received rofecoxib in the post-operative period than the other two groups (P = 0.02). The number of rescue narcotic medications taken by patients on day 1 were 3.0 (2.4) [mean (SD)] in the placebo group, 2.2 (1.7) (P <0.001) in the post-operative only group, and 2.9 (2.3) (P = 0.37) in the peri-operative group. There was no statistical significance between the physical health composite scores or the mental health composite scores at 6 weeks. Conclusion: The use of post-operative rofecoxib decreases the amount of pain post-operatively after inguinal herniorrhaphy and decreases the number of rescue narcotic medications used, but it does not change the quality of life. This effect is lacking in the peri-operative group. There is no evidence to recommend the routine use of rofecoxib or similar COX-2 inhibitors after inguinal hernia surgery.