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罗哌卡因伤口浸润在甲状腺手术中缺乏镇痛效果:一项随机、双盲、安慰剂对照试验

Lack of Analgesic Effect Induced by Ropivacaine Wound Infiltration in Thyroid Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.

作者信息

Miu Mihaela, Royer Catherine, Gaillat Carmen, Schaup Barbara, Menegaux Fabrice, Langeron Olivier, Riou Bruno, Aubrun Frédéric

机构信息

From the Departments of *Anesthesia and Critical Care, †General Surgery, and ‡Emergency Medicine, Pitié-Salpetrière Hospital, Pierre et Marie Curie University, Paris, France; and §Department of Anesthesia and Critical Care, Croix-Rousse Hospital, Claude Bernard Lyon 1 University, Lyon, France.

出版信息

Anesth Analg. 2016 Feb;122(2):559-64. doi: 10.1213/ANE.0000000000001041.

Abstract

BACKGROUND

Surgical site infiltration with local anesthetic reduces analgesic requests in various types of surgeries. Because thyroid surgery may induce severe postoperative pain, we tested the hypothesis that ropivacaine surgical site infiltration would significantly decrease postoperative administration of morphine in patients undergoing thyroid surgery.

METHODS

We performed a double-blind, placebo-controlled superiority trial to assess the efficacy of surgical site analgesia with ropivacaine (10 mL, 75 mg) performed at the end of thyroid surgery in adult patients. The primary end point was the proportion of patients not requiring IV morphine in the postanesthesia care unit.

RESULTS

One hundred sixty-three patients completed the study, 85 in the placebo group and 88 in the ropivacaine group. The proportion of patients requiring morphine administration in the postanesthesia care unit (55% vs 53%, P = 0.80), the dose of IV morphine administered (5.6 ± 6.1 vs 5.5 ± 6.0 mg, P = 0.90), the total dose of opioids administered (expressed as oral morphine equivalent dose: 64 ± 27 vs 69 ± 29 mg, P = 0.20), and the visual analog pain scale over the first 24 hours were not significantly different between groups. The incidence of adverse events (36% vs 39%, P = 0.88), morphine-related adverse events (19% vs 17%, P = 0.84), serious adverse events (0% vs 2%, P = 0.50), and the patient satisfaction scores (9 ± 1 vs 9 ± 1, P = 0.70) was not significantly different between the 2 groups.

CONCLUSIONS

Surgical site analgesia with ropivacaine at the end of thyroid surgery is not associated with any significant analgesic benefit.

摘要

背景

局部麻醉剂进行手术部位浸润可减少各类手术中的镇痛需求。由于甲状腺手术可能引发严重的术后疼痛,我们检验了以下假设:罗哌卡因手术部位浸润能显著减少甲状腺手术患者术后吗啡的使用量。

方法

我们进行了一项双盲、安慰剂对照的优效性试验,以评估在成年患者甲状腺手术结束时使用罗哌卡因(10毫升,75毫克)进行手术部位镇痛的效果。主要终点是麻醉后护理单元中不需要静脉注射吗啡的患者比例。

结果

163名患者完成了研究,安慰剂组85名,罗哌卡因组88名。麻醉后护理单元中需要使用吗啡的患者比例(55%对53%,P = 0.80)、静脉注射吗啡的剂量(5.6±6.1对5.5±6.0毫克,P = 0.90)、使用的阿片类药物总剂量(以口服吗啡等效剂量表示:64±27对69±29毫克,P = 0.20)以及最初24小时的视觉模拟疼痛量表评分在两组之间无显著差异。不良事件发生率(36%对39%,P = 0.88)、与吗啡相关的不良事件发生率(19%对17%,P = 0.84)、严重不良事件发生率(0%对2%,P = 0.50)以及患者满意度评分(9±1对9±1,P = 0.70)在两组之间无显著差异。

结论

甲状腺手术结束时使用罗哌卡因进行手术部位镇痛未带来任何显著的镇痛益处。

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