Preemptive versus postoperative lumiracoxib for analgesia in ambulatory arthroscopic knee surgery

Abstract

We compared the efficacy and safety of preemptive vs postoperative dosing of lumiracoxib 400 mg in patients undergoing minor ambulatory arthroscopic knee surgery. Eligible patients were randomized to preemptive lumiracoxib, postoperative lumiracoxib, and placebo. The main efficacy parameter was pain intensity (PI) (0-100 mm visual analog scale) in the target knee upon movement, 2 hours after surgery. Other efficacy variables included PI in the target knee at rest and upon movement at 1, 3, 4, and 24 hours, time to first rescue medication intake. In the lumiracoxib preemptive and postoperative groups, the estimated treatment difference compared to placebo for primary endpoint was -4.0 (95% CI: -9, -1; p = 0.007) and -3.5 (95% CI: -8.5, 0; p = 0.052), respectively. There was no statistical significant difference between two active treatment groups (p = 0.602). Both preemptive and postoperative lumiracoxib resulted in significantly lower PI scores at rest and after movement at all time-points and no statistically significant difference was observed between the active treatments. Time to rescue medication intake was comparable for both active treatments. The proportion of adverse events was similar among all groups. We conclude that the efficacy of lumiracoxib 400 mg is not affected by the timing of administration (preemptive or postoperative).

Keywords: NSAIDs; arthroscopic knee surgery; arthroscopy; lumiracoxib; postoperative pain; preemptive dosing.

Figure 1

Patient disposition.

Figure 2

Pain intensity over time (ITT population, LOCF). Notes: *p ≤ 0.05; **p ≤ 0.01; p ≤ 0.001 lumiracoxib 400 mg preemptive vs placebo; ^†p ≤ 0.05; ^††p ≤ 0.01; ^†††p ≤ 0.001 lumiracoxib 400 mg postoperative vs placebo; No significant differences were observed between given preemptive and postoperative lumiracoxib 400 mg; Wilcoxon rank sum test stratified by center.

Figure 3

Time to first rescue medication (ITT population). Notes: ^†p = 0.003 vs placebo, ^‡p = 0.001 vs placebo; n = intent-to-treat patients per treatment group; p-values calculated using logrank test.