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术中艾司洛尔和乳腺癌手术后疼痛:一项随机临床试验。

Intra-operative esmolol and pain following mastectomy: A randomised clinical trial.

机构信息

From the Department of Anaesthesiology, Base Hospital of the Federal District, Brasilia, DF (FTM, AJT, HIM, LFS) and Cardiology Department, State University of Campinas (Unicamp), Campinas, Sao Paulo, Brazil (LSFdC, ACS).

出版信息

Eur J Anaesthesiol. 2021 Jul 1;38(7):735-743. doi: 10.1097/EJA.0000000000001512.


DOI:10.1097/EJA.0000000000001512
PMID:33831899
Abstract

BACKGROUND: Esmolol is a beta-1 selective blocker that has been shown to reduce postoperative pain. Its antinociceptive effects have not been tested following mastectomy. OBJECTIVE: To evaluate the safety, efficacy and antinociception of intra-operative esmolol infusion after mastectomy. DESIGN: Randomised, double-blinded, placebo-controlled trial. SETTING: Tertiary referral centre, Brasília, Brazil. Recruitment: July 2015 to July 2017. PATIENTS: Seventy women scheduled for mastectomy, ASA I to III, aged 18 to 75 years. Four were excluded. INTERVENTIONS: All underwent general anaesthesia. The intervention group received a bolus of 0.5 mg kg-1 of esmolol over 10 min followed by a continuous infusion of 100 μg kg-1 min-1. The placebo group received saline. MAIN OUTCOME MEASURES: The primary outcome was pain at rest 24 h after mastectomy as measured by a 0 to 10 numeric rating scale. RESULTS: Pain scores at rest 24 h after mastectomy were lower in esmolol-treated patients compared with placebo (mean difference = -1.51, 95% confidence interval (CI), -2.36 to -0.65, P = 0.001). On arrival in the postanaesthesia care unit (PACU), the occurrence of pain was also lower in the esmolol group, at rest and on effort (P = 0.009 and P = 0.013, respectively), on discharge from PACU (P = 0.009 and P = 0.015), 12 h (P = 0.01 and P = 0.007) and on effort in the 24 postoperative hours (P = 0.003). Mean morphine consumption was reduced by 77% in the esmolol group compared with the placebo group (mean difference  = -2.52 mg, 95% CI = -3.67 to -1.38, P < 0.001). The length of hospital stay was shorter for the esmolol group (mean difference = -6.9 h, 95% CI, -13.4 to -0.31, P = 0.040). CONCLUSION: Esmolol was well tolerated, allowed a notable reduction in the dose of rescue analgesics and demonstrated superior efficacy compared to placebo for pain management after mastectomy. TRIAL REGISTRATION: ClinicalTrials/NCT02466542.

摘要

背景:艾司洛尔是一种β-1 选择性阻滞剂,已被证明可减轻术后疼痛。但其在乳房切除术后的抗伤害作用尚未经过测试。

目的:评估乳房切除术后术中给予艾司洛尔输注的安全性、疗效和镇痛效果。

设计:随机、双盲、安慰剂对照试验。

地点:巴西巴西利亚的三级转诊中心。招募:2015 年 7 月至 2017 年 7 月。

患者:70 名拟行乳房切除术的 ASA I 至 III 级女性,年龄 18 至 75 岁。有 4 名患者被排除。

干预措施:所有患者均接受全身麻醉。干预组接受 0.5mg/kg 的艾司洛尔静脉推注 10 分钟,然后以 100μg/kg/min 的速度持续输注。安慰剂组给予生理盐水。

主要观察指标:主要结局是乳房切除术后 24 小时静息时的疼痛程度,采用 0 至 10 的数字评分量表进行评估。

结果:与安慰剂组相比,艾司洛尔治疗组患者术后 24 小时静息时的疼痛评分更低(平均差值=-1.51,95%置信区间(CI):-2.36 至-0.65,P=0.001)。在进入麻醉后护理病房(PACU)时,艾司洛尔组在静息和用力时疼痛的发生也较低(P=0.009 和 P=0.013),从 PACU 出院时(P=0.009 和 P=0.015)、12 小时(P=0.01 和 P=0.007)和术后 24 小时用力时(P=0.003)。与安慰剂组相比,艾司洛尔组的吗啡消耗量减少了 77%(平均差值=-2.52mg,95%CI:-3.67 至-1.38,P<0.001)。艾司洛尔组的住院时间较短(平均差值=-6.9 小时,95%CI:-13.4 至-0.31,P=0.040)。

结论:艾司洛尔耐受性良好,与安慰剂相比,可显著减少解救镇痛药物的剂量,并在乳房切除术后疼痛管理方面表现出优于安慰剂的疗效。

试验注册:ClinicalTrials/NCT02466542。

相似文献

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[10]
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