Original article
Analgesic Efficacy of Perioperative Celecoxib in Ambulatory Arthroscopic Knee Surgery: A Double-Blind, Placebo-Controlled Study

https://doi.org/10.1016/j.arthro.2006.03.012Get rights and content

Purpose: To examine whether celecoxib, administered perioperatively, reduces opioid consumption and opioid-related adverse effects, and provides effective analgesia, in patients undergoing ambulatory arthroscopic knee meniscectomy. Methods: Patients (≥18 years) with diagnosed knee meniscus disease were given celecoxib (400 mg; n = 99) or placebo (n = 101) 1 hour before they underwent arthroscopic knee surgery; this was followed by celecoxib (200 mg) or placebo given postoperatively at their first request for pain medication. Surgery was performed with patients under general anesthesia (fentanyl, 1 to 3 μg/kg plus 0.25% intra-articular bupivacaine, 10 to 20 mL) administered at the index joint. Every 4 to 6 hours, patients were allowed 1 to 2 tablets of hydrocodone bitartrate 5 mg/acetaminophen 500 mg (and optional opioids as needed). All efficacy analyses were conducted in the modified intent-to-treat population. Results: In the 24 hours following surgery, total opioid consumption was significantly reduced in the celecoxib group (3.6 tablets) compared with the placebo group (4.6 tablets; P = .009). Celecoxib was associated with significant reductions in opioid consumption compared with placebo at 10 to 12 hours (P = .005) and at 12 to 24 hours (P = .012). The percentage of placebo-treated patients (41%) who required opioid analgesics was significantly greater than the percentage of celecoxib-treated patients who required opioids (22%; P = .008) at 10 to 12 hours. Adverse events (AEs) were experienced by more patients in the placebo group (37%) than in the celecoxib group (18%). Incidences of opioid-related events, such as central nervous system disorders (12% v 3%, respectively) and constipation (5% v 1%, respectively), were higher in placebo-treated patients than in those given celecoxib. Conclusions: Perioperative administration of celecoxib plus optional opioids reduces the use of opioids and the occurrence of opioid-related AEs compared with treatment with placebo plus optional opioids given to patients undergoing arthroscopic knee meniscectomy. Level of Evidence: Level I, randomized, double-blind, placebo-controlled, parallel-group study.

Section snippets

Study Design and Patient Selection

This was a randomized, double-blind, placebo-controlled, parallel-group study that was conducted at 9 sites in the United States. Patients (aged ≥18 years) with meniscal disease who required arthroscopic knee surgery (arthroscopic meniscectomy and partial meniscectomy) were included. Patients were excluded if they had experienced osteoarthritis or inflammatory arthritis affecting the index joint, a previous fracture of the index joint, a required repair of the meniscus, reconstructive

Baseline Demographic Characteristics

Of the 200 patients randomized to the study, 99 (49.5%) received celecoxib and 101 (50.5%) were given placebo. The mITT population (patients who remained in the study and completed the 24-hour assessment) comprised 166 patients (Fig 1). No significant differences between the 2 study groups were observed in any of the baseline characteristics (Table 1).

Efficacy Analyses

Total opioid analgesic (hydrocodone bitartrate/APAP tablets) consumption at 24 hours was significantly lower in patients receiving celecoxib (3.6

Discussion

This study examined the analgesic efficacy and opioid-sparing effects of the COX-2 selective inhibitor, celecoxib, when administered before and after arthroscopic knee surgery. Our findings show that celecoxib plus optional opioids provided improved analgesia and a reduction in opioid use compared with placebo plus optional opioids. Patients who had received celecoxib required 1 less hydrocodone bitartrate/APAP tablet over 24 hours after surgery, and they experienced fewer opioid-related AEs

Conclusions

This multimodal regimen, which uses a COX-2 selective inhibitor perioperatively, is an effective opioid-sparing option for the management of postoperative pain. This study shows that the multimodal approach to pain management with perioperative administration of celecoxib, in addition to hydrocodone/APAP, provides well-tolerated, efficacious postoperative analgesia for patients undergoing arthroscopic knee surgery while reducing opioid utilization.

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