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临床试验/NCT06371456
NCT06371456尚未招募不适用

Anon Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery

Ain Shams University0 个研究点目标入组 100 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
appearance of the dew sign

研究概览

简要总结

Epidural anesthesia for pain control during normal vaginal delivery is a blind maneuver and so we need a confirmatory sign for being in the correct epidural space.

Loss of resistance sign using air may guide us wrongly as it may occur if we entered into the paravertebral muscles or cavities in the interspinal ligaments.

So, additional confirmatory sign beside loss of resistance sign by air is strongly needed.

We noticed that after occurence of loss of resistance sign by air and insertion of the epidural catheter a dew was formed on the internal sides of the epidural catheter after aspiration to be sure that there are no blood or cerebrospinal fluid in the catheter.

This dew formation (Ramy sign) is characteristic for air in the epidural space when transferred from the warm epidural space (temperature about 38-39 celsius degree) to the colder aspect of the catheter outside the patient which nearly has the same operating room temperature (22 celsius degree).

This sign may be associated with correct placement and good function of the epidural catheter.

详细描述

parturient for normal vaginal delivery are examined for correct epidural catheter placement by loss of resistance technique by air, observation of the dew sign and epidurogram.

Visual analogue score is used to test pain. blood pressure and heart rate after epidural injection will be monitored

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Parturient for normal vaginal delivery
  • American society of anesthesiologists 2

排除标准

  • patients refusal
  • back infection
  • anticoagulant non stopped
  • platelets count less than 100000
  • international normalization ratio more than 1.4
  • severe cardiac or respiratory diseases
  • haemodynamics unstable patients

结局指标

主要结局

appearance of the dew sign

时间窗: immediately during aspiration of the epidural catheter

dew formation inside the outer portion of the epidural catheter near the patient

次要结局

  • mean blood pressure(30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%)
  • heart rate(30 minutes after epidural injection by 10 milliliter bupivacaine 0.25%)
  • epidurogram(immediately after epidural catheter insertion)
  • visual analogue score(20 minutes after epidural injection by 10 milliliter bupivacaine 0.25%)

研究者

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

RAMY AHMED

Assistant Professor of Anesthesia

Ain Shams University

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