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全膝关节置换术后静脉注射与口服对乙酰氨基酚作为多模式镇痛辅助用药的前瞻性、随机、双盲临床试验

Intravenous vs Oral Acetaminophen as an Adjunct to Multimodal Analgesia After Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind Clinical Trial.

作者信息

O'Neal Jason B, Freiberg Andrew A, Yelle Marc D, Jiang Yandong, Zhang Chengwei, Gu Yin, Kong Xiangyi, Jian Wenling, O'Neal Wesley T, Wang Jingping

机构信息

Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee.

Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.

出版信息

J Arthroplasty. 2017 Oct;32(10):3029-3033. doi: 10.1016/j.arth.2017.05.019. Epub 2017 May 18.

Abstract

BACKGROUND

The efficacy of intravenous (IV) acetaminophen compared with its oral formulation for postoperative analgesia is unknown. We hypothesized that the addition of acetaminophen to a multimodal analgesia regimen would provide improved pain management in patients after total knee arthroplasty (TKA) and that the effect of acetaminophen would be variable based on the route of delivery.

METHODS

The study was a single-center, randomized, double-blinded, placebo-controlled clinical trial on the efficacy of IV vs oral acetaminophen in patients undergoing unilateral TKA. One hundred seventy-four subjects were randomized to one of the 3 groups: IV acetaminophen group (IV group, n = 57) received 1 g IV acetaminophen and oral placebo before postanesthesia care unit (PACU) admission; oral acetaminophen group (PO group, n = 58) received 1 g oral acetaminophen and volume-matched IV normal saline; placebo group (Placebo group, n = 59) received oral placebo and volume-matched IV normal saline. Pain scores were obtained every 15 minutes during PACU stay. Average pain scores, maximum pain score, and pain scores before physical therapy were compared among the 3 groups. Secondary outcomes included total opiate consumption, time to PACU discharge, time to rescue analgesia, and time to breakthrough pain.

RESULTS

The average PACU pain score was similar in the IV group (0.56 ± 0.99 [mean ± standard deviation]) compared with the PO group (0.67 ± 1.20; P = .84) and Placebo group (0.58 ± 0.99; P = .71). Total opiate consumption at 6 hours (0.47 mg hydromorphone equivalents ± 0.56 vs 0.54 ± 0.53 vs 0.54 ± 0.61; P = .69) and at 24 hours (1.25 ± 1.30 vs 1.49 ± 1.34 vs 1.36 ± 1.31; P = .46) were also similar between the IV, PO, and Placebo groups. No significant differences were found between all groups for any other outcome.

CONCLUSION

Neither IV nor oral acetaminophen provides additional analgesia in the immediate postoperative period when administered as an adjunct to multimodal analgesia in patients undergoing TKA in the setting of a spinal anesthetic.

摘要

背景

静脉注射对乙酰氨基酚与口服制剂相比用于术后镇痛的疗效尚不清楚。我们假设在多模式镇痛方案中添加对乙酰氨基酚可改善全膝关节置换术(TKA)患者的疼痛管理,并且对乙酰氨基酚的效果会因给药途径而异。

方法

本研究是一项关于静脉注射与口服对乙酰氨基酚对接受单侧TKA患者疗效的单中心、随机、双盲、安慰剂对照临床试验。174名受试者被随机分为3组之一:静脉注射对乙酰氨基酚组(IV组,n = 57)在进入麻醉后护理单元(PACU)前接受1 g静脉注射对乙酰氨基酚和口服安慰剂;口服对乙酰氨基酚组(PO组,n = 58)接受1 g口服对乙酰氨基酚和等体积的静脉注射生理盐水;安慰剂组(安慰剂组,n = 59)接受口服安慰剂和等体积的静脉注射生理盐水。在PACU停留期间每15分钟记录一次疼痛评分。比较3组之间的平均疼痛评分、最大疼痛评分和物理治疗前的疼痛评分。次要结局包括总阿片类药物消耗量、PACU出院时间、补救镇痛时间和突破性疼痛时间。

结果

IV组(0.56±0.99[平均值±标准差])的平均PACU疼痛评分与PO组(0.67±1.20;P = 0.84)和安慰剂组(0.58±0.99;P = 0.71)相似。IV组、PO组和安慰剂组在6小时(0.47 mg氢吗啡酮等效物±0.56 vs 0.54±0.53 vs 0.54±0.61;P = 0.69)和24小时(1.25±1.30 vs 1.49±1.34 vs 1.36±1.31;P = 0.46)的总阿片类药物消耗量也相似。在所有组之间的任何其他结局方面均未发现显著差异。

结论

在脊髓麻醉情况下,对于接受TKA的患者,当作为多模式镇痛的辅助药物给药时,静脉注射或口服对乙酰氨基酚在术后即刻均未提供额外的镇痛作用。

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