A prospective, randomized, comparative trial of a COX-2 selective nonsteroidal anti-inflammatory drug versus placebo in inguinal herniorrhaphy patients

Abstract

The standard opioid treatment for postoperative pain can be associated with nausea, vomiting, and constipation. In addition, opioids often provide insufficient pain relief. The purpose of this study was to compare postoperative pain and functional outcomes in patients undergoing inguinal herniorrhaphy who receive a COX-2 selective nonsteroidal anti-inflammatory drug (COX-2) or placebo preoperatively and for 4 days postoperatively. A prospective, randomized, blinded, placebo-controlled trial was conducted in adults undergoing elective, outpatient, unilateral inguinal herniorrhaphy. Patients received rofecoxib (50 mg, 1 h prior to incision) or placebo. Doses were re-administered once daily on postoperative days 1-4. Patients were also given hydrocodone bitartrate for use as needed in the postoperative period. Pain outcomes were assessed, including pain intensity (1-10 visual-analogue scale) and the use of hydrocodone bitartrate. In addition, functional outcomes such as activity and return of bowel function were examined for 5 postoperative days. Incidence and severity of side effects were examined. Statistics are mean +/- standard deviation. Fifty-five subjects completed the study. Twenty-six patients received rofecoxib and 29 patients received placebo. Patients who received COX-2 demonstrated improved bowel function as reflected by more bowel movements on postoperative day 2 and postoperative day 3. COX-2-treated patients also reported better oral intake on these same days. In addition, COX-2-treated patients had less difficulty coughing on postoperative day 1. Overall satisfaction with pain management was better in COX-2-treated patients (very satisfied vs. satisfied). There were no statistically significant differences between groups in the amount of hydrocodone bitartrate consumption. There were no complications during the study period. Administration of a COX-2 selective nonsteroidal anti-inflammatory drug prior to and following outpatient inguinal herniorrhaphy improves functional outcomes when compared with placebo and increases patient satisfaction. These results suggest that multimodal pain therapy with COX-2 inhibitors may have a role in outpatient inguinal hernia repair.