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与患者自控硬膜外镇痛相比,程控间歇硬膜外推注是否能改善初产妇的分娩条件?:一项多中心、随机、对照、三盲研究。

Does programmed intermittent epidural bolus improve childbirth conditions of nulliparous women compared with patient-controlled epidural analgesia?: A multicentre, randomised, controlled, triple-blind study.

机构信息

From the Department of Anesthesiology and Critical Care Medicine, Hopital Universitaire Arnaud de Villeneuve, Montpellier (EM, MJ, CD), Department of Anesthesiology and Critical Care Medicine Pôle Anesthesie-Reanimation-Estaing, Clermont-Ferrand (BS, MB), Clinical Research and Epidemiology Unit, Medical Information Department, Hopital Universitaire Montpellier, Montpellier (EN, NN), Department of Anesthesiology and Intensive Care, Hopital Universitaire Femme Me[Combining Grave Accent]re Enfant, Hospices Civils de Lyon, Lyon (DC) and Department of Anesthesiology and Critical Care Medicine, Hopitaux Universitaires Paris-Sud, AP-HP, Paris, France (DB).

出版信息

Eur J Anaesthesiol. 2019 Oct;36(10):755-762. doi: 10.1097/EJA.0000000000001053.

DOI:10.1097/EJA.0000000000001053
PMID:31335447
Abstract

BACKGROUND

Epidural analgesia may change the mechanics of childbirth. These changes are related to the concentration of the local anaesthetic used epidurally but probably also to its mode of delivery into the epidural space.

OBJECTIVE

To determine whether the administration of programmed intermittent epidural boluses (PIEB) improves the mechanics of second-stage labour compared with patient-controlled epidural analgesia (PCEA) with a background infusion.

DESIGN

A randomised, controlled, triple-blind study.

SETTING

Multicentre study including four level III maternity units, January 2014 until June 2016.

PATIENTS

A total of 298 nulliparous patients in spontaneous labour were randomised to a PIEB or PCEA group.

INTERVENTION

After epidural initiation with 15 ml of 0.1% levobupivacaine containing 10 μg of sufentanil, patients received either an hourly bolus of 8 ml (PIEB) or a continuous rate infusion of 8 ml h (PCEA): the drug mixture used was levobupivacaine 0.1% and sufentanil 0.36 μg ml.

MAIN OUTCOME MEASURES

The primary outcome was a composite endpoint of objective labour events: a posterior occiput position in the second stage, an occiput position at birth, waiting time at full cervical dilatation before active maternal pushing more than 3 h, maternal active pushing duration more than 40 min, and foetal heart rate alterations. Vaginal instrumental delivery rates, analgesia and motor blockade scores were also recorded.

RESULTS

From the 298 patients randomised, data from 249 (124 PIEB, 125 PCEA) were analysed. No difference was found in the primary outcome: 48.0% (PIEB) and 45.5% (PCEA) of patients, P = 0.70. In addition, no difference was observed between the groups for each of the individual events of the composite endpoint, nor in the instrumental vaginal delivery rate, nor in the degree of motor blockade. Despite an equivalent volume of medication in the groups, a significantly higher analgesia score at full dilatation was observed in the PIEB group, odds-ratio = 1.9 (95% confidence interval, 1.0 to 3.5), P = 0.04.

CONCLUSION

The mechanics of the second stage did not differ whether PIEB or PCEA was used. Analgesic conditions appeared to be superior with PIEB, especially at full dilation.

TRIAL REGISTRATION

NCT01856166.

摘要

背景

硬膜外镇痛可能改变分娩力学。这些变化与硬膜外使用的局部麻醉剂的浓度有关,但可能也与它进入硬膜外腔的输送方式有关。

目的

确定与背景输注下的患者自控硬膜外镇痛(PCEA)相比,程序化间歇硬膜外推注(PIEB)是否能改善第二产程的力学。

设计

一项随机、对照、三盲研究。

地点

包括四个三级产科单位的多中心研究,2014 年 1 月至 2016 年 6 月。

患者

298 例自发性分娩的初产妇随机分为 PIEB 或 PCEA 组。

干预

在 15ml 含 10μg舒芬太尼的 0.1%左旋布比卡因硬膜外起始后,患者接受每小时 8ml 推注(PIEB)或 8ml/h 持续输注(PCEA):使用的药物混合为 0.1%左旋布比卡因和 0.36μg/ml 舒芬太尼。

主要结局测量

主要结局是客观分娩事件的综合终点:第二产程时后枕骨位置、出生时枕骨位置、完全宫颈扩张后产妇主动用力超过 3 小时的等待时间、产妇主动用力时间超过 40 分钟、胎儿心率改变。阴道器械分娩率、镇痛和运动阻滞评分也被记录。

结果

在 298 例随机患者中,有 249 例(PIEB 124 例,PCEA 125 例)的数据进行了分析。主要结局无差异:48.0%(PIEB)和 45.5%(PCEA)的患者,P=0.70。此外,复合终点的各个事件、器械性阴道分娩率、运动阻滞程度在两组之间也无差异。尽管两组的用药量相同,但 PIEB 组在完全扩张时的镇痛评分显著更高,比值比=1.9(95%置信区间,1.0 至 3.5),P=0.04。

结论

第二产程的力学特征在使用 PIEB 或 PCEA 时没有差异。PIEB 时的镇痛条件似乎更好,尤其是在完全扩张时。

试验注册

NCT01856166。

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