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临床试验/NCT02792933
NCT02792933已完成不适用

Localization of the Epidural Space Using the Loss of Resistance Technique for Labour Analgesia: A Randomized Controlled Trial Comparing Air Versus Saline Solution

Instituto de Investigación Hospital Universitario La Paz0 个研究点目标入组 400 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
主要终点
Analgesia obtained 30 minutes after the puncture of the epidural block (variation of pain score)

研究概览

简要总结

Epidural space localization using loss of resistance technique with air (ALOR) is controversial in obstetric analgesia due to a minor efficacy and risk of complications, compared with loss of resistance technique with saline (SLOR). This randomized prospective study will compare the efficacy and incidence of most common complications of both techniques in obstetric analgesia.

详细描述

A local ethics committee has approved the study. A statistical power calculation was performed and 177 patients per group will be necessary to confirm a 20% difference of efficacy of the block at 30 minutes (α=0,05; β=0,1). Epidural catheter will be inserted and a standardized analgesic protocol will initiate. The efficacy of the block will be assessed after 30 minutes and at delivery. The apparition of adverse effects during puncture and labour will be annotated. The need for repuncture of the block and the repercussion of the technique on the delivery and the fetus will be recorded as well. At 24 hours, investigators will assess the incidence of pain at the site of puncture (PSP) and the level of maternal satisfaction on a 0 to10 numeric scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Analgesia obtained 30 minutes after the puncture of the epidural block (variation of pain score)

时间窗: 30 min

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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