Effect of Local Anesthetic Solution at Different Temperatures for Epidural Labor Analgesia on Intrapartum Fever: A Randomized Clinical Trial.

Hai-Chao Wei,Ying Cao,Xiao-Yang Wu,Meng-Meng Cai,Jia-Feng Sun,Wei-Chun Tang,Bo-Xiang Du
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Abstract

BACKGROUND Whether heating local anesthetic solutions to core body temperature (37°C) for epidural labor analgesia reduces intrapartum fever incidence remains undefined in the current literature. METHODS This double-blind randomized controlled trial (RCT) enrolled 220 nulliparous parturients (18-35 years, American Society of Anesthesiologists [ASA] physical status II, term singleton pregnancy). Participants were randomized to receive epidural labor analgesia with 0.075% ropivacaine + 0.5 µg/mL sufentanil at 37°C (warmed group) or 22°C (room-temperature group). Epidurals were placed at L3-L4 with a test dose of 3 mL of 1.5% lidocaine at room temperature, followed by programmed bolus epidural analgesia (initial 10 mL, 10 mL/h) and patient-controlled epidural analgesia (PCEA) 5 mL (30-minute lockout). Tympanic temperature was measured every 30 minutes from epidural initiation to delivery, defining intrapartum fever as ≥38°C. The primary outcome was fever incidence, on which the power analysis was based, and also maximum temperature and shivering. Secondary outcomes comprised analgesia onset, block level, labor durations, neonatal Apgar scores, umbilical cord blood pH and BE, and maternal adverse events. RESULTS A total of 220 parturients were included (warmed group, n = 110; room-temperature group, n = 110). The warmed group had a lower intrapartum fever incidence (15.5% [17/110] vs 30.9% [34/110], relative risk [RR] 0.5 [95% confidence interval {CI}, 0.298-0.840]; P = .007); however, the reduction of 49.8% did not reach the preset clinically meaningful difference of 60% reduction proposed in the power analysis. The maximum body temperature was also lower in the warmed group: median (interquartile range [IQR]) 37.4 (IQR, 37.2-37.7) °C vs 37.6 (IQR, 37.3-38.0) °C, median difference -0.2 (95% CI, -0.3 to -0.1) °C (P = .006). Shivering incidence was not different between groups (10.9% [12/110] vs 14.5% [16/110]; P = .418). No statistically significant differences were observed between groups in any of the secondary outcomes assessed, including block characteristics, local anesthetic consumption, labor duration, neonatal outcomes, and maternal adverse events. CONCLUSION Although we found a 50% reduction in the incidence of temperature rise using warmed (37°C) local anesthetics for epidural labor analgesia, this did not reach our preset threshold of 60% reduction.
不同温度局麻液硬膜外分娩镇痛对产时发热的影响:一项随机临床试验。
背景:将局麻药溶液加热至核心体温(37℃)用于硬膜外分娩镇痛是否能减少产时发热的发生率,目前的文献尚未明确。方法本双盲随机对照试验(RCT)纳入220例无产产妇(年龄18-35岁,美国麻醉学会[ASA]身体状态II级,单胎妊娠期)。受试者随机接受0.075%罗哌卡因+ 0.5µg/mL舒芬太尼在37℃(暖组)或22℃(室温组)的硬膜外分娩镇痛。硬膜外放置于L3-L4,室温下1.5%利多卡因试验剂量3ml,随后进行计划性硬膜外灌注镇痛(初始10ml, 10ml /h)和患者自控硬膜外镇痛(PCEA) 5ml(30分钟闭锁)。从硬膜外启动到分娩,每30分钟测量一次鼓室温度,将产时发热定义为≥38°C。主要结果是发热发生率,这是功效分析的基础,还有最高体温和颤抖。次要结局包括镇痛开始、阻滞水平、分娩持续时间、新生儿Apgar评分、脐带血pH和BE以及产妇不良事件。结果共纳入产妇220例(加温组110例,常温组110例)。取暖组产中发热发生率较低(15.5% [17/110]vs 30.9%[34/110],相对危险度[RR] 0.5[95%可信区间{CI}, 0.298-0.840], P = .007);然而,49.8%的减少并没有达到功率分析中提出的60%的临床意义差异。温暖组的最高体温也较低:中位数(四分位数间距[IQR]) 37.4 (IQR, 37.2-37.7)°C vs 37.6 (IQR, 37.3-38.0)°C,中位数差-0.2 (95% CI, -0.3至-0.1)°C (P = 0.006)。两组间寒战发生率无差异(10.9% [12/110]vs 14.5% [16/110]; P = .418)。在评估的任何次要结局中,包括阻滞特征、局部麻醉消耗、分娩持续时间、新生儿结局和产妇不良事件,两组之间没有统计学上的显著差异。结论:虽然我们发现使用加热(37°C)局麻药进行硬膜外分娩镇痛时体温升高的发生率降低了50%,但这并没有达到我们预设的降低60%的阈值。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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