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临床试验/NCT04981353
NCT04981353Unknown不适用

Thoracic Erector Spinae Plane Block for painless1st Stage Normal Vaginal Delivery: Randomized Controlled Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年7月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
1. numerical rating pain score (NRS) during the course of delivery

研究概览

简要总结

this study will test a novel indication for bilateral erector spinae plane block (painless 1st stage normal vaginal delivery) it depends on the hypnosis that the erector spinae plane block blocks the visceral pain also by affecting the ventral rami, dorsal rami and rami communicants.

详细描述

Aim of the work In this article, the efficacy of bilateral thoracic (ESP) to provide painless delivery without affecting the motor power (walking painless labor) will be studded.

The main objective:

  1. numerical rating pain score (NRS) during the course of delivery will be recorded and compared.

Other objectives:

  1. the total doses of pethidine needed through-out delivery will be measured
  2. the incidence of failed delivery and need of cesarean section will be assessed
  3. the incidence of transient fetal bradycardia or deceleration after the administration of the block will be recorded
  4. ABGAR score of the neonate immediately after delivery and after 5min, 10min,15min after delivery. Will be recorded

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant ladies 37-40 weeks of gestation scheduled for normal vaginal delivery ASA 2 either prime or multipara

排除标准

  • pregnant ladies with complicated pregnancy eg; IUGR,accidental hemorrhage, preeclampsia pregnant ladies scheduled for cesarean section

结局指标

主要结局

1. numerical rating pain score (NRS) during the course of delivery

时间窗: every 30 minutes throughout the delivery

1. numerical rating pain score (NRS) during the course of delivery will be recorded and compared

次要结局

  • 2. the incidence of failed delivery and need of cesarean section will be assessed(throughout delivery time)
  • 3. the incidence of transient fetal bradycardia or deceleration after the administration of the block will be recorded(immediately after administration of the block)
  • 4. ABGAR score of the neonate immediately after delivery and after 5min, 10min,15min after delivery. Will be recorded(at birth , after 5 min., 10min., 15 min.)
  • 1. the total doses of pethidine needed through-out delivery will be measured(throughout the first stage of delivery)

研究者

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

Asmaa adel

lecturer of anesthesia and intensive care MD

Ain Shams University

研究点 (1)

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