经硬膜外针与导管注射负荷剂量后分娩镇痛起效的比较研究：一项前瞻性、双盲、随机临床试验。

Comparative study of labour analgesia onset with injection of loading dose through epidural needle versus catheter: A prospective, double-blinded, randomised clinical trial.

作者信息

Chen XiaoPing, Tang YingYing, Yu QingQing, Sun LiHong, Li Hua, Wang LuYang, Jiao Cuicui, Chen XinZhong

机构信息

From the Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China (XC, YT, QY, LS, HL, LW, CJ, XC).

出版信息

Eur J Anaesthesiol. 2025 Feb 1;42(2):113-121. doi: 10.1097/EJA.0000000000002077. Epub 2024 Oct 16.

DOI:10.1097/EJA.0000000000002077

PMID:39744745

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11676590/

Abstract

BACKGROUND

Rapid onset of epidural analgesia is an important concern for the parturient. Commonly, the local anaesthetic mixture is administered through the epidural catheter. Drugs administered through the epidural needle might decrease the onset time and enhance the spread of medication within the epidural space.

OBJECTIVES

The primary aim of this study was to compare the onset time of analgesia when a loading dose of dilute local anaesthetic opioid mixture was injected through either the Tuohy needle or a single end-hole epidural catheter.

DESIGN

A prospective, double-blinded, randomised clinical trial.

SETTING

Single university hospital, from November 2022 to August 2023.

PARTICIPANTS

A total of 200 healthy nulliparous women who requested epidural analgesia for labour were randomly allocated to the needle group (n = 100) or the catheter group (n = 100).

INTERVENTIONS

In the needle group, after identification of the epidural space, a test dose of 3 ml 0.1% ropivacaine with 0.3 μg ml-1 sufentanil was injected through the Tuohy needle followed 3 min later by a 15 ml loading dose of the same mixture over 30 s. Then the catheter was inserted into the epidural space. In the catheter group, after identification of the epidural space, a catheter was advanced into the epidural space and the ropivacaine/sufentanil mixture was injected in an identical manner though the catheter.

MAIN OUTCOME MEARSURES

The primary outcome was the onset time of labour analgesia (defined as the time from drug administration to adequate analgesia). Adequate analgesia was defined as a visual analogue score 10 mm or less during uterine contractions.

RESULTS

Median [IQR] onset time of labour analgesia did not differ significantly between the two groups (needle group: 20 [16 to 30] minutes; catheter group: 20 [15 to 25] minutes, P = 0.232).

CONCLUSION

Compared with bolus injection though a single end-hole epidural catheter, injection through the epidural needle did not shorten the analgesia onset time for adequate labour analgesia.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT05594771).

摘要

背景

硬膜外镇痛的快速起效是产妇关注的重要问题。通常，局部麻醉混合剂通过硬膜外导管给药。通过硬膜外针给药可能会缩短起效时间并增强药物在硬膜外间隙内的扩散。

目的

本研究的主要目的是比较通过 Tuohy 针或单端孔硬膜外导管注射稀释的局部麻醉阿片类混合剂负荷剂量时的镇痛起效时间。

设计

一项前瞻性、双盲、随机临床试验。

地点

单一大学医院，2022 年 11 月至 2023 年 8 月。

参与者

共有 200 名要求进行分娩硬膜外镇痛的健康未产妇被随机分配到针组（n = 100）或导管组（n = 100）。

干预措施

在针组中，确定硬膜外间隙后，通过 Tuohy 针注射 3 ml 含 0.3 μg/ml 舒芬太尼的 0.1% 罗哌卡因试验剂量，3 分钟后在 30 秒内注射 15 ml 相同混合剂的负荷剂量。然后将导管插入硬膜外间隙。在导管组中，确定硬膜外间隙后，将导管推进硬膜外间隙，并通过导管以相同方式注射罗哌卡因/舒芬太尼混合剂。