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Bilateral Thoracic Paravertebral Blocks Compared to Thoracic Epidural Analgesia After Midline Laparotomy:A Pragmatic Noninferiority Clinical Trial
背景与目的
有研究报道腹部手术中双侧椎旁神经阻滞（PVB）是胸段硬膜外镇痛（TEA）的一种强有效的替代方法。本临床试验旨在确定在胸外科手术术后PVB与TEA镇痛作用的比较。
方 法
70例ASA分级I-III级进行胸外科手术患者，随机分为TEA（TEA组）及连续双侧PVB（PVB组），两组均进行开放设计的多模镇痛方案 。若术后24小时运动时疼痛的组间平均评分差异在0-10数值评分量表（NRS）的2分范围内，则两组间镇痛作用无差异。 次要指标为术后72小时内静息和运动时疼痛评分、镇痛药物消耗量、血流动力学和不良事件的发生情况。
结 果
术后24小时运动时疼痛评分在PVB组与TEA组无显著性差异（95%CI：0.43 [-0.72 -1.58]）；休息及其他运动时间点疼痛评分在两组的变化均在临床可接受范围内，且随着时间的推移，两组之间无显著差异。动脉血浆罗哌卡因水平在安全限值内。
结 论
作为多模式镇痛的一个重要组成部分，，双侧PVB在胸外科手术患者的镇痛作用与TEA相似。
原始文献摘要
Rakesh V. Sondekoppam, Vishal Uppal, Jonathan Brookes,etal;Bilateral Thoracic Paravertebral Blocks Compared to Thoracic Epidural Analgesia After Midline Laparotomy:A Pragmatic Noninferiority Clinical Trial;ANESTHESIA & ANALGESIA;2019.
BACKGROUND: Bilateral paravertebral block (PVB) is a suitable alternative to thoracic epidural analgesia (TEA) for abdominal surgeries. This randomized clinical trial aims to determine if PVB is noninferior to TEA in terms of analgesia after midline laparotomy.
METHODS: Seventy American Society of Anesthesiologists (ASA) class I–III patients undergoing a laparotomy through a midline incision were randomized to receive either TEA (TEA group) or continuous bilateral PVB (PVB group) as a part of a multimodal analgesia regimen in an openlabel design. Noninferiority was to be concluded if the mean between-group difference in pain on movement at the 24 postoperative hours was within a margin of 2 points on a 0–10 numerical rating scale (NRS). Pain score at rest and on movement, analgesic consumption, hemodynamics, and adverse events during the first 72 postoperative hours were the secondary outcome measures assessed for superiority. Postblock and steady-state plasma concentrations of ropivacaine and pattern of dye spread were also recorded in the PVB group.
RESULTS: The primary outcome of pain scores on movement at 24 postoperative hours was noninferior in PVB group in comparison to TEA group (mean difference [95% confidence interval {CI}], 0.43 [−0.72–1.58]). The pain scores at rest and on movement at other time points of assessment were within clinically acceptable limits in both groups with no significant differences between the groups over time. Arterial plasma ropivacaine levels were within safe limits,
while steady-state venous level was higher than an acceptable threshold in 9 of 34 cases.
CONCLUSIONS: As a component of multimodal analgesia, bilateral PVB provides noninferior analgesia compared to TEA for midline laparotomy.
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翻译：王贵龙 编辑：何幼芹 审校：王贵龙
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