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ANALGESIA

Nimesulide 90 mg Orally Twice Daily Does Not Influence Postoperative Morphine Requirements After Major Chest Surgery

Donal F. Harney^*, Michelle Dooley^*, Brendan Harhen^*, Niall McGuiness, Gerard Cagney^*, Connail McCrory, Desmond J. Fitzgerald^*, and Noreen P. Dowd

From the *Department of Clinical Pharmacology, Royal College of Surgeons, Department of Anaesthesia, St. James’s Hospital, Dublin, Ireland; and Independent Data Management, Cork, Ireland.

Address correspondence to Dr. Donal Harney, Department of Pain Medicine. Mercy University Hospital, Cork, Ireland. Address e-mail to donalharney{at}hotmail.com.

Abstract

BACKGROUND: Cyclooxygenase 2 inhibition has proven analgesic efficacy in a variety of surgical procedures. We postulated that perioperative cyclooxygenase 2 inhibition significantly reduces postoperative morphine requirements after major thoracic surgery and investigated the site of this potential analgesic effect.

METHODS: Ninety-two patients participated in this single-center, double-blind, randomized, placebo-controlled, parallel-group trial. Patients between the ages of 18 and 80 yr undergoing a thoracotomy or median sternotomy were randomized to receive either nimesulide or placebo in combination with a standard analgesic regimen perioperatively. Nimesulide was administered orally the evening before surgery and at 12-h intervals for 5 days postoperatively. The primary efficacy variables were morphine consumption and pain scores for the first 48 h postoperatively. The secondary efficacy variable was the effect of nimesulide on cyclooxygenase activity in cerebrospinal fluid (CSF).

RESULTS: Pain scores at rest or with movement, and total morphine consumption for the first 48 h postoperatively, were not statistically different between the groups. The mean difference in total morphine consumption up to 48 h postoperatively between the nimesulide and placebo group was a 9.0 mg reduction (95% CI: –28.9 to 10.9 mg) (P = 0.37). Adjusted mean (se) CSF 6-keto-PGF1 (6-keto-PGF1) concentrations increased by 54.7 (25.7) pg/mL from preoperatively to Day + 2 postoperatively in the placebo group, whereas adjusted mean (se) CSF 6-keto-PGF1 concentration decreased by 0.6 pg/mL (18.2 pg/mL) in the nimesulide group. These changes were not statistically different between the groups (P = 0.095).

CONCLUSION: Nimesulide, at a dose of 90 mg twice daily in combination with a standard analgesic regimen, does not influence pain scores, morphine requirements, or CSF prostaglandin levels after major thoracic surgery.