罗哌卡因 0.08%复合舒芬太尼 0.3μg/mL 用于分娩镇痛的程控间断硬膜外阻滞最佳注药间隔时间：偏倚硬币上下序贯分配试验。
Optimum interval time of programmed intermittent epidural bolus of ropivacaine 0.08% with sufentanyl 0.3 μg/mL for labor analgesia: a biased-coin up-and-down sequential allocation trial.
机构信息
Department of Anesthesia, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai 201204, China.
Department of Anesthesia, Fujian Provincial Maternity and Children's Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian 350001, China.
出版信息
Chin Med J (Engl). 2020 Mar 5;133(5):517-522. doi: 10.1097/CM9.0000000000000669.
BACKGROUND
The programmed intermittent epidural bolus (PIEB) technique is widely used in labor analgesia, but the parameter settings of PIEB have not yet been standardized. We designed a study to identify the optimal interval duration for PIEB using 10 mL of ropivacaine 0.08% and sufentanyl 0.3 μg/mL, a regimen commonly used to control labor pain in China, to provide effective analgesia in 90% of women during the first stage of labor without breakthrough pain.
METHODS
We conducted a double-blind sequential allocation trial to obtain the effective interval 90% (EI90%) during the first stage of labor between April 2019 and May 2019. This study included the American Society of Anesthesiologists physical status II-III nulliparous parturients at term, who requested epidural analgesia. The bolus volume was fixed at 10 mL of ropivacaine 0.08% with sufentanyl 0.3 μg/mL. Participants were divided into four groups (groups 60, 50, 40, and 30) according to the PIEB intervals (60, 50, 40, and 30 min, respectively). The interval duration of the first parturient was set at 60 min and that of subsequent parturients varied according to a biased-coin design. The truncated Dixon and Mood method and the isotonic regression analysis method were used to estimate the EI90% and its 95% confidence intervals (CIs).
RESULTS
Forty-four women were enrolled in this study. The estimated optimal interval was 44.1 min (95% CI 41.7-46.5 min) and 39.5 min (95% CI 32.5-50.0 min), using the truncated Dixon and Mood method and isotonic regression analysis, respectively. The maximum sensory block level above T6 was in nearly 20% of parturients in group 30; however, 5.3%, 0%, and 0% of the parturients presented with sensory block level above T6 in groups 40, 50, and 60, respectively. There were no cases of hypotension and only one parturient complained of motor block.
CONCLUSION
With a fixed 10 mL dose of ropivacaine 0.08% with sufentanyl 0.3 μg/mL, the optimal PIEB interval is about 42 min. Further studies are warranted to define the efficacy of this regimen throughout all stages of labor.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR1900022199; http://www.chictr.org.cn/com/25/historyversionpuben.aspx?regno=ChiCTR1900022199.
背景
程控间歇硬膜外推注（PIEB）技术广泛应用于分娩镇痛，但 PIEB 的参数设置尚未标准化。我们设计了一项研究，旨在使用 10 毫升罗哌卡因 0.08%和舒芬太尼 0.3μg/ml 确定 PIEB 的最佳间隔时间，这是中国控制分娩疼痛的常用方案，以在第一产程中为 90%的女性提供有效的镇痛，而不会出现突破性疼痛。
方法
我们于 2019 年 4 月至 5 月进行了一项双盲序贯分配试验，以获得第一产程中的有效间隔 90%（EI90%）。本研究纳入了美国麻醉医师协会体格状况 II-III 级的足月初产妇，要求硬膜外镇痛。推注量固定为 10 毫升罗哌卡因 0.08%加舒芬太尼 0.3μg/ml。根据 PIEB 间隔（分别为 60、50、40 和 30 分钟），参与者被分为四组（60、50、40 和 30 组）。第一产程的间隔时间设定为 60 分钟，随后产程的间隔时间根据偏倚硬币设计而变化。使用截断 Dixon 和 Mood 法和等渗回归分析方法估计 EI90%及其 95%置信区间（CI）。
结果
本研究纳入了 44 名女性。使用截断 Dixon 和 Mood 法和等渗回归分析，估计最佳间隔分别为 44.1 分钟（95%CI 41.7-46.5 分钟）和 39.5 分钟（95%CI 32.5-50.0 分钟）。在 30 组中，近 20%的产妇出现最高感觉阻滞水平在 T6 以上；然而，在 40、50 和 60 组中，分别有 5.3%、0%和 0%的产妇出现 T6 以上的感觉阻滞水平。没有低血压病例，只有 1 名产妇抱怨运动阻滞。
结论
使用固定剂量的 10 毫升罗哌卡因 0.08%加舒芬太尼 0.3μg/ml，PIEB 的最佳间隔约为 42 分钟。需要进一步研究以确定该方案在整个分娩阶段的疗效。
试验注册
中国临床试验注册中心，ChiCTR1900022199；http://www.chictr.org.cn/com/25/historyversionpuben.aspx?regno=ChiCTR1900022199。
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