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塞来昔布用于髋关节镜术后早期疼痛管理的疗效:一项前瞻性随机安慰剂对照研究。

Efficacy of Celecoxib for Early Postoperative Pain Management in Hip Arthroscopy: A Prospective Randomized Placebo-Controlled Study.

作者信息

Kahlenberg Cynthia A, Patel Ronak M, Knesek Michael, Tjong Vehniah K, Sonn Kevin, Terry Michael A

机构信息

Department of Orthopaedic Surgery, Northwestern University, Feinberg School of Medicine, Chicago, Illinois, U.S.A..

Department of Orthopaedic Surgery, Northwestern University, Feinberg School of Medicine, Chicago, Illinois, U.S.A.

出版信息

Arthroscopy. 2017 Jun;33(6):1180-1185. doi: 10.1016/j.arthro.2017.01.016. Epub 2017 Mar 1.

Abstract

PURPOSE

To determine whether 400 mg of celecoxib administered 1 hour before hip arthroscopy surgery would reduce pain, provide reduction in overall narcotic consumption, and lead to more rapid discharge from recovery rooms.

METHODS

Ninety-eight patients were randomized to either the celecoxib group (n = 50) or the placebo group (n = 48). An a priori power analysis was done set to detect a difference of 0.50 on the visual analog scale (VAS), based on the senior author's preference. The number of patients planned for recruitment was rounded up to 100 to allow for flexibility in the study. Inclusion criteria were any patient at least 18 years old who underwent hip arthroscopy surgery performed by the senior author. All patients had less than Tönnis grade 2 arthritis. Exclusion criteria were allergy to sulfa-based drugs, prior adverse reaction to celecoxib, or patients who were on chronic narcotics for whom alternative pain management regimens were arranged before surgery. Randomization was performed on a 1:1 basis in blocks of 10 using sealed envelopes stating celecoxib or placebo. One hour before surgery, all patients received either 400 mg celecoxib or placebo. Patients were evaluated using a VAS preoperatively, immediately postoperatively, and at 1 and 2 hours postoperatively. Time from the operating room to "ready for discharge" and number of morphine equivalents of narcotic medication required in the postanesthesia care unit were recorded.

RESULTS

Age and preoperative VAS were similar between the celecoxib and placebo control group, with average ages of 34.2 ± 11.9 and 35.8 ± 11.6 (P = .27) and preoperative VAS of 2.1 ± 2.06 and 2.3 ± 1.98 (P = .29), respectively. The celecoxib group had 26 females and 24 males, whereas the placebo group had 29 females and 19 males (P = .42). The most common surgical procedures were labral repair (31 patients in the celecoxib group and 29 patients in the placebo group), and labral repair with acetabular osteoplasty (13 patients in the celecoxib group and 11 patients in the placebo group). There were no significant differences in procedures performed between the 2 groups (P > .05). At 1 hour postoperatively, patients who received celecoxib had a lower pain score that was statistically significant compared with the placebo group (4.6 vs 5.4, P = .03). There was a significant difference in discharge time between patients who received celecoxib and the control group (152.9 minutes vs 172.9 minutes, P = .04). There was no significant difference found in morphine equivalents consumed in the postanesthesia care unit between the 2 groups (15.3 vs 15.4, P = .48).

CONCLUSIONS

A preoperative dose of 400 mg of celecoxib led to statistically significantly reduced patient-reported pain on the VAS in the acute postoperative period after hip arthroscopy surgery, though the difference is not likely clinically significant. There was a significantly shorter time to discharge in patients who received celecoxib versus placebo.

LEVEL OF EVIDENCE

Level I, randomized controlled trial.

摘要

目的

确定在髋关节镜手术前1小时服用400毫克塞来昔布是否能减轻疼痛、减少总体麻醉药物用量,并使患者更快地从恢复室出院。

方法

98例患者被随机分为塞来昔布组(n = 50)或安慰剂组(n = 48)。根据资深作者的偏好,进行了一项预先设定的功效分析,旨在检测视觉模拟量表(VAS)上0.50的差异。计划招募的患者数量向上取整至100名,以便在研究中具有灵活性。纳入标准为年龄至少18岁、接受资深作者实施髋关节镜手术的任何患者。所有患者的关节炎均小于Tönnis 2级。排除标准为对磺胺类药物过敏、既往对塞来昔布有不良反应,或正在使用慢性麻醉药物且术前已安排替代疼痛管理方案的患者。使用标明塞来昔布或安慰剂的密封信封,以1:1的比例按10个一组进行随机分组。手术前1小时,所有患者服用400毫克塞来昔布或安慰剂。术前、术后即刻、术后1小时和2小时使用VAS对患者进行评估。记录从手术室到“准备出院”的时间以及麻醉后护理单元所需麻醉药物的吗啡当量。

结果

塞来昔布组和安慰剂对照组的年龄及术前VAS相似,平均年龄分别为34.2±11.9岁和35.8±11.6岁(P = 0.27),术前VAS分别为2.1±2.06和2.3±1.98(P = 0.29)。塞来昔布组有26名女性和24名男性,而安慰剂组有29名女性和19名男性(P = 0.42)。最常见的手术操作是盂唇修复(塞来昔布组31例患者,安慰剂组29例患者)以及盂唇修复联合髋臼截骨术(塞来昔布组13例患者,安慰剂组11例患者)。两组之间的手术操作无显著差异(P>0.05)。术后1小时,服用塞来昔布的患者疼痛评分低于安慰剂组,差异具有统计学意义(4.6对5.4,P = 0.03)。服用塞来昔布的患者与对照组的出院时间存在显著差异(152.9分钟对172.9分钟,P = 0.04)。两组在麻醉后护理单元消耗的吗啡当量无显著差异(15.3对15.4,P = 0.48)。

结论

术前服用400毫克塞来昔布可使髋关节镜手术后急性期患者报告的VAS疼痛在统计学上显著减轻,尽管该差异在临床上可能不显著。与安慰剂相比,服用塞来昔布的患者出院时间明显更短。

证据水平

I级,随机对照试验。

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