胸神经阻滞II型的前瞻性双盲随机安慰剂对照临床试验

B. Versyck, G. Geffen, P. V. Houwe
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引用次数: 93

摘要

区域麻醉技术用于乳房手术后急性和持续性疼痛,胸神经阻滞II型(Pecs)是一种易于实施的浅表阻滞技术,在胸大肌和胸小肌之间沉积局麻药。局麻药的这种分布阻断了胸神经、肋臂间神经、III-VI肋间神经和胸长神经。这项前瞻性、随机、双盲、安慰剂对照试验旨在评估Pecs block减少阿片类药物消耗的假设,并且在乳房手术患者中至少与围手术期镇痛药一样好,如果不是更好的话。本研究的主要结局指标是数值评定量表疼痛评分和术中及术后阿片类药物消耗。次要结果测量是患者满意度评分。研究数据包括美国麻醉医师学会生理评分1-3分(年龄18-80岁)的I - III期乳腺癌患者,接受乳房切除术或乳房肿瘤切除术并前哨淋巴结或腋窝淋巴结清扫。患者按1:1的比例随机分为研究组(Pecs组,10ml左布比卡因0.25%)或对照组(安慰剂组,生理盐水)。每组70例。在麻醉后护理单位(PACU)停留时间每隔15分钟记录一次疼痛评分,在病房前24小时每隔2小时记录一次疼痛评分,接下来的24小时每隔4小时记录一次疼痛评分。在整个住院期间记录术中和术后阿片类药物的消耗,并在出院时使用10分制评估患者满意度。使用IBM Statistical Package for Social Science Statistics version 21进行统计分析,P < 0.05认为有统计学意义。PACU住院期间,Pecs组患者疼痛程度低于对照组(P = 0.048)。Pecs组术中舒芬太尼需求量与安慰剂组相当(8.0±3.5 μg和7.8±3.0 μg, P = 0.730)。与对照组相比,Pecs组患者术后所需阿片类药物(9.16±10.15 mg和14.97±14.38 mg, P = 0.037)和术后阿片类药物给药干预明显减少(P = 0.045)。两组患者均对护理非常满意(10分制评分分别为9.6±0.6和9.1±1.8,P = 0.211)。综上所述,在麻醉过程中加入Pecs阻滞可显著减少PACU的疼痛和阿片类药物需求,证实了Pecs阻滞在乳房手术术后镇痛中的有效性。
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Prospective Double Blind Randomized Placebo-Controlled Clinical Trial of the Pectoral Nerves (Pecs) Block Type II
STUDY OBJECTIVE The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN A prospective randomized double blind placebo-controlled study. SETTING A secondary hospital. PATIENTS 140 breast cancer stage 1-3 patients undergoing mastectomy or tumorectomy with sentinel node or axillary node dissection. INTERVENTIONS Patients were randomized to receive either a Pecs block with levobupivacaine 0.25% (n=70) or placebo block with saline (n=70). MEASUREMENTS The pain levels were evaluated by Numeric Rating Scale (NRS) pain scores at 15-minute intervals during the post anesthesia care unit stay time (PACU), at 2-hour intervals for the first 24h on the ward and at 4-hour intervals for the next 24h. Intraoperative and postoperative opioid consumption were recorded during the full stay. Patient satisfaction was evaluated upon discharge using a 10-point scale. MAIN RESULTS Intraoperative sufentanil requirements were comparable for the Pecs and placebo group (8.0±3.5μg and 7.8±3.0μg, P=0.730). Patients in the Pecs group experienced significantly less pain than patients in the control group (P=0.048) during their PACU stay. Furthermore, patients in the Pecs group required significant less postoperative opioids (9.16±10.15mg and 14.97±14.38mg morphine equivalent, P=0.037) and required significant fewer postsurgical opioid administration interventions than patients in the control group (P=0.045). Both patient-groups were very satisfied about their management (9.6±0.6 and 9.1±1.8 on a 10-point scale, P=0.211). CONCLUSIONS The Pecs block reduces postsurgical opioid consumption during the PACU stay time for patients undergoing breast surgery.
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