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不同浓度罗哌卡因用于分娩镇痛的程控间断硬膜外推注容量优化:偏倚硬币上下序贯分配试验。

Optimization of programmed intermittent epidural bolus volume for different concentrations of ropivacaine in labor analgesia: a biased coin up-and-down sequential allocation trial.

机构信息

Department of Anesthesiology of Ya'an People's Hospital, Ya'an, China.

Department of Anesthesiology of The Second People's Hospital of Yibin, Yibin, China.

出版信息

BMC Pregnancy Childbirth. 2022 Jul 25;22(1):590. doi: 10.1186/s12884-022-04912-8.

Abstract

BACKGROUND AND OBJECTIVES

To date, programmed intermittent epidural bolus (PIEB) has been widely used in obstetric analgesia, while no optimal PIEB regimen has been proposed. This study aimed to assess effective analgesia in 90% of women (EV90) with different concentrations of ropivacaine (0.075% and 0.1%) combined with 0.5 µg/mL sufentanil, at an interval of 40 min using the biased coin design-up-and-down method (BCD-UDM), and to explore whether there is a difference in EV90 with the increase of ropivacaine concentration.

METHODS

In total, 103 primiparous women were assigned to two groups, including group A (n = 52) and group B (n = 51). Parturients in group A were treated with 0.075% ropivacaine and 0.5 µg/mL sufentanil, while those in group B were treated with 0.1% ropivacaine and 0.5 µg/mL sufentanil. Used the biased coin up-and-down sequential allocation method to determine the EV90. The secondary outcomes were sensory block level, motor block, and adverse events (hypotension, urinary retention, and pruritus).

RESULTS

The results revealed that EV90 was 10 mL (95% confidence interval (CI):8.03-11.54) in group A, and EV90 was 9 mL (95% CI:7.49-10.51) in group B by the isotonic regression method. The highest level of the sensory block was T8, and the lowest was T12. No case of hypotension was recorded,and only 4 parturients complained of motor block.

CONCLUSION

With an interval of 40 min, the optimal PIEB bolus volume of 0.075% ropivacaine and 0.5 µg/mL sufentanil was 10 mL, 0.1% ropivacaine and 0.5 µg/mL sufentanil was 9 mL. Moreover, the PIEB volume decreased along with the higher concentration of ropivacaine.

TRIAL REGISTRATION

ChiCTR registration number: ChiCTR2000040917 . Registration date: December 15, 2020.

摘要

背景与目的

目前,程控间断硬膜外推注(PIEB)已广泛应用于产科镇痛,但尚未提出最佳 PIEB 方案。本研究旨在采用偏倚硬币上下设计(BCD-UDM)评估 0.075%和 0.1%罗哌卡因分别复合 0.5μg/ml 舒芬太尼用于 90%产妇有效镇痛的最小推注剂量(EV90),间隔 40min,同时探索罗哌卡因浓度增加是否会对 EV90 产生影响。

方法

本研究纳入 103 例初产妇,分为 A 组(n=52)和 B 组(n=51)。A 组产妇接受 0.075%罗哌卡因和 0.5μg/ml 舒芬太尼治疗,B 组产妇接受 0.1%罗哌卡因和 0.5μg/ml 舒芬太尼治疗。采用偏倚硬币上下序贯分配方法确定 EV90。次要结局指标包括感觉阻滞平面、运动阻滞和不良事件(低血压、尿潴留和瘙痒)。

结果

采用等比回归法,A 组 EV90 为 10ml(95%置信区间(CI):8.03-11.54),B 组 EV90 为 9ml(95%CI:7.49-10.51)。感觉阻滞最高平面为 T8,最低平面为 T12。未发生低血压,仅有 4 例产妇诉有运动阻滞。

结论

间隔 40min,0.075%罗哌卡因复合 0.5μg/ml 舒芬太尼的最佳 PIEB 推注量为 10ml,0.1%罗哌卡因复合 0.5μg/ml 舒芬太尼的最佳 PIEB 推注量为 9ml。而且,随着罗哌卡因浓度的升高,PIEB 推注量减少。

试验注册

ChiCTR 注册号:ChiCTR2000040917 。注册日期:2020 年 12 月 15 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d670/9310404/ee0ec46e1733/12884_2022_4912_Fig1_HTML.jpg

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