Department of Anesthesia, Cedars Sinai Medical Center, Los Angeles, California, USA.
Anesth Analg. 2011 Feb;112(2):323-9. doi: 10.1213/ANE.0b013e3182025a8a. Epub 2010 Dec 14.
Nonsteroidal antiinflammatory drugs have become increasingly popular as part of multimodal analgesic regimens for pain management in the ambulatory setting. We designed this randomized, double-blind, placebo-controlled study to evaluate the effect of postoperative administration of either a nonselective nonsteroidal antiinflammatory drug (ibuprofen) or the cyclooxygenase-2 selective inhibitor (celecoxib when administered as part of a multimodal analgesic regimen) on the severity of pain, the need for rescue analgesics, and clinically relevant patient outcomes after ambulatory surgery. The primary end point was the time to resumption of normal activities of daily living.
One hundred eighty patients undergoing outpatient surgery were randomly assigned to 1 of 3 treatment groups: group 1 (control) received either 2 placebo capsules (matching celecoxib) or 1 placebo tablet (matching ibuprofen) in the recovery room and 1 placebo tablet at bedtime on the day of surgery, followed by 1 placebo capsule or tablet 3 times a day for 3 days after discharge; group 2 (celecoxib) received celecoxib 400 mg (2 capsules) orally in the recovery room and 1 placebo capsule and tablet at bedtime on the day of surgery, followed by celecoxib 200 mg (1 capsule) twice a day + placebo capsule every day at bedtime for 3 days after surgery; or group 3 (ibuprofen) received ibuprofen 400 mg (1 tablet) orally in the recovery room and 400 mg orally at bedtime on the day of surgery, followed by 400 mg orally 3 times a day for 3 days after surgery. Recovery times, postoperative pain scores, and the need for rescue analgesics were recorded before discharge. Follow-up evaluations were performed at 24 hours, 48 hours, 72 hours, 7 days, and 30 days after surgery to assess postdischarge pain, analgesic requirements, resumption of normal activities, opioid-related side effects, as well as quality of recovery and patient satisfaction with their postoperative pain management using a 5-point verbal rating scale.
The 3 groups did not differ with respect to their demographic characteristics. Compared with the placebo treatment, both celecoxib and ibuprofen significantly decreased the need for rescue analgesic medication after discharge (P < 0.05). The effect sizes (celecoxib and ibuprofen versus control group) were 0.73 to 1 and 0.3 to 0.8, respectively. Quality of recovery scores and patient satisfaction with their postoperative pain management were also improved in the celecoxib and ibuprofen groups compared with the control group (P < 0.05, effect size [vs control group] = 0.67). The incidence of postoperative constipation was significantly higher in the control group (28%) compared with the celecoxib (5%) and ibuprofen (7%) groups, respectively (P < 0.05). Both active treatments were well tolerated in the postdischarge period. However, the time to resumption of normal activities of daily living was similar among the 3 groups.
Both ibuprofen (1200 mg/d) and celecoxib (400 mg/d) significantly decreased the need for rescue analgesic medication in the early postdischarge period, leading to an improvement in the quality of recovery and patient satisfaction with their pain management after outpatient surgery.
非甾体抗炎药已成为多模式镇痛方案的一部分,在门诊环境中用于疼痛管理,越来越受到欢迎。我们设计了这项随机、双盲、安慰剂对照研究,以评估术后给予非选择性非甾体抗炎药(布洛芬)或环氧化酶-2 选择性抑制剂(塞来昔布)作为多模式镇痛方案的一部分,对疼痛严重程度、需要解救性镇痛药物以及术后门诊手术相关的临床相关患者结局的影响。主要终点是恢复日常生活活动的时间。
180 名接受门诊手术的患者被随机分配到 3 个治疗组之一:第 1 组(对照组)在恢复室接受 2 个安慰剂胶囊(与塞来昔布匹配)或 1 个安慰剂片剂(与布洛芬匹配),并在手术当天睡前服用 1 个安慰剂片剂,然后在出院后 3 天内每天服用 1 个安慰剂胶囊或片剂 3 次;第 2 组(塞来昔布组)在恢复室口服塞来昔布 400mg(2 胶囊),并在手术当天睡前服用 1 个安慰剂胶囊和片剂,然后在手术后每天睡前服用塞来昔布 200mg(1 胶囊)和安慰剂胶囊,出院后 3 天每天服用 1 次;或第 3 组(布洛芬组)在恢复室口服布洛芬 400mg(1 片),并在手术当天睡前口服 400mg,然后在手术后每天口服 400mg,每天 3 次。在出院前记录恢复时间、术后疼痛评分和需要解救性镇痛药物。在手术后 24 小时、48 小时、72 小时、7 天和 30 天进行随访评估,以评估出院后疼痛、镇痛需求、恢复正常活动、阿片类药物相关副作用以及使用 5 分制口头评分量表评估患者对术后疼痛管理的恢复质量和满意度。
3 组在人口统计学特征方面无差异。与安慰剂治疗相比,塞来昔布和布洛芬均显著减少了出院后对解救性镇痛药物的需求(P<0.05)。效应大小(塞来昔布和布洛芬与对照组)分别为 0.73 至 1 和 0.3 至 0.8。与对照组相比,塞来昔布和布洛芬组的恢复质量评分和患者对术后疼痛管理的满意度也得到了改善(P<0.05,与对照组相比的效应大小[vs 对照组]为 0.67)。与塞来昔布(5%)和布洛芬(7%)组相比,对照组(28%)术后便秘的发生率明显更高(P<0.05)。两种活性治疗药物在出院后期间均耐受良好。然而,3 组恢复日常生活活动的时间相似。
布洛芬(1200mg/d)和塞来昔布(400mg/d)均显著减少了出院后早期对解救性镇痛药物的需求,改善了门诊手术后的恢复质量和患者对疼痛管理的满意度。