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
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
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DOI：
10.1213/ane.0000000000005141
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发表时间：
2021-03-01
影响因子：
5.7
通讯作者：
Mhyre, Jill M.
中科院分区：
文献类型：
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作者：
Sharawi, Nadir;Bansal, Prannal;Mhyre, Jill M.
背景：对于紧急产时剖宫产（CD），文献不支持使用任何特定的局麻溶液将硬膜外镇痛扩展到剖宫产麻醉。我们假设，3%氯普鲁卡因（CP）将是非劣效于2%利多卡因，150微克的肾上腺素，2毫升的8.4%碳酸氢盐的混合物，和100微克的芬太尼（LEBF）在手术anesthesia.METHODS：在这个单中心随机非劣效性试验，成年健康妇女接受CD随机分配到硬膜外麻醉与CP或LEBF。在进入手术室（OR）进行择期CD之前，建立T10的感觉阻滞（针刺）。到达手术室后，参与者以标准化的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”。“主要结果是T7水平触觉丧失的时间。非劣效性界值设定为3分钟。次要结局是需要术中镇痛补充。结果：总共有70名女性参加了该研究。在T7皮区水平达到双侧感觉阻滞触摸的平均起效时间，CP组为655（标准差[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至204;非劣效性P = 0.10）。平均差异的90% CI上限超过预先规定的3分钟非劣效性界值。术中镇痛的要求2 groups.CONCLUSION：这两种麻醉剂的解决方案有一个快速的麻醉起效时，用于延长低剂量硬膜外感觉阻滞手术麻醉的差异没有意义。本研究的数据不足以证实CP在CD的快速硬膜外扩张麻醉中非劣效于LEBF，需要进一步研究来确定非劣效性。
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 mu g of epinephrine, 2 mL of 8.4% bicarbonate, and 100 mu g 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 outcome 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.CONCLUSION: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.