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临床试验/NCT04776512
NCT04776512Unknown不适用

Lumbar Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor

Mongi Slim Hospital0 个研究点目标入组 50 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Analgesia during labor

研究概览

简要总结

Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery.

At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups:

  • ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process.
  • Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia.

详细描述

Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery.

At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups:

  • ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process.
  • Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia.

For the first group: 20 ml of 0,375% isobaric Bupivacain solution will be injected bilaterally under ultrasound direct vision.

Concerning the second group, patients will have a continuous injection of 0,125% Bupivacain solution associated to 0,25 mcg of Sufentanil/ml through an epidural catheter in the L3-L4 or L4-L5 intervertebral space.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Full termed parturients admitted for vaginal delivery
  • singleton pregnancy
  • No contraindications to perimedullar analgesia techniques

排除标准

  • Indication to Cesarean section during labor period

结局指标

主要结局

Analgesia during labor

时间窗: change in VAS score 1 hour after the beginning of labor

analgesia assessed using VAScore

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mhamed Sami Mebazaa

Professor head of anesthesia and intensive care department

Mongi Slim Hospital

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