氯普鲁卡因与利多卡因联合肾上腺素、碳酸氢钠和芬太尼用于择期剖宫产硬膜外延长麻醉中的比较：一项随机、三盲、非劣效性研究

2021-07-13 米勒之声

当使用低剂量硬膜外感觉阻滞扩展到手术麻醉时，两种麻醉方案都有快速的麻醉发作。目前的研究数据不足以证实CP对于CD的快速硬膜外延长麻醉是否不如LEBF，还需要进一步的研究来确定其非劣效性。

氯普鲁卡因与利多卡因联合肾上腺素、碳酸氢钠和芬太尼用于择期剖宫产硬膜外延长麻醉中的比较：一项随机、三盲、非劣效性研究

贵州医科大学高鸿教授课题组

翻译：潘志军编辑：佟睿审校：曹莹

Part.01

背景

对于急诊剖宫产(CD)，文献不支持使用任何特定的局麻药液来将硬膜外镇痛延长到剖宫产麻醉。我们假设3%氯普鲁卡因(CP)在手术麻醉的起效时间方面不劣于2%利多卡因、150 µg肾上腺素、2mL 8.4%碳酸氢盐和100 µg芬太尼 (LEBF)的混合物。

Part.02

方法

在这个单中心随机非劣效性试验中，将成年健康女性CD患者随机分配到CP或LEBF硬膜外麻醉。择期CD进入手术室前，对其进行T10感觉阻滞(针刺)。到达手术室后，参与者以标准化方式接受硬膜外研究药物，以模拟“硬膜外分娩镇痛到手术麻醉”的转换。主要观察指标是在T7水平失去触觉的时间。非劣边际设为3分钟。次要观察指标是术中需要补充的镇痛量。

Part.03

结果

总共有70名女性参加了这项研究。CP组在T7皮刀水平实现双侧感觉阻滞的平均起效时间为655（标准偏差[SD] = 258）秒，LEBF组为558（269）秒，平均差异为97秒（90%置信区间[CI]，SD = -10.6~204；非劣效性P = 0.10）。平均差的90% CI上限超过了预先指定的3分钟非劣效性界限。两组对术中镇痛的要求没有显著差异。

Part.04

结论

Part.05

原始文献来源

Nadir Sharawi, Prannal Bansal, Matthew Williams, et al. Comparison of Chloroprocaine Versus Lidocaine With Epinephrine, Sodium Bicarbonate, and Fentanyl for Epidural Extension Anesthesia in Elective Cesarean Delivery: A Randomized, Triple-Blind, Noninferiority Study.[J].(Anesth Analg . 2021 Mar 1;132(3):666-675).

英文摘要

Comparison of Chloroprocaine Versus Lidocaine With Epinephrine, Sodium Bicarbonate, and Fentanyl for Epidural Extension Anesthesia in Elective Cesarean Delivery: A Randomized, Triple-Blind, Noninferiority Study

Background: For emergent intrapartum cesarean delivery (CD), the literature does not support the use of any particular local anesthetic solution to extend epidural analgesia to cesarean anesthesia. We hypothesized that 3% chloroprocaine (CP) would be noninferior to a mixture of 2% lidocaine, 150 µg of epinephrine, 2 mL of 8.4% bicarbonate, and 100 µg of fentanyl (LEBF) in terms of onset time to surgical anesthesia.

Methods: In this single-center randomized noninferiority trial, adult healthy women undergoing CD were randomly assigned to epidural anesthesia with either CP or LEBF . Sensory blockade (pinprick) to T10 was established before operating room (OR) entry for elective CD. On arrival to the OR, participants received the epidural study medications in a standardized manner to simulate the conversion of“epidural labor analgesia to surgical anesthesia.”The primary out-come was the time to loss of touch sensation at the T7 level. A noninferiority margin was set at 3 minutes. The secondary outcome was the need for intraoperative analgesia supplementation.

Results: In total, 70 women were enrolled in the study. The mean onset time to achieve a bilateral sensory block to touch at the T7 dermatome level was 655 (standard deviation [SD] = 258) seconds for group CP and 558 (269) seconds for group LEBF , a difference in means of 97 seconds (90% confidence interval [CI], SD = −10.6 to 204; P = .10 for noninferiority). The upper limit of the 90% CI for the mean difference exceeded the prespecified 3-minute noninferiority margin. There

was no meaningful difference in the requirement for intraoperative analgesia between the 2 groups.

Conclusions: Both anesthetic solutions have a rapid onset of anesthesia when used to extend low-dose epidural sensory block to surgical anesthesia. Data from the current study provide insufficient evidence to confirm that CP is noninferior to LEBF for rapid epidural extension anesthesia for CD, and further research is required to determine noninferiority.