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临床试验/NCT03437889
NCT03437889已完成不适用

Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip on Obese Parturients

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Measure of bilateral decrease of sensation to cold with ice

研究概览

简要总结

Pregnant women, with a Body Mass Index (BMI) greater than 30 kg/m2, who receive epidural analgesia/anesthesia for childbirth will have epidural catheter placement per our standard procedure, which includes using the gravity flow technique to confirm that the tip (aperture) of the epidural needle is indeed located within the epidural space. The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen between 10 and 30 minutes after the epidural catheter is inserted. Hypesthesia to cold will be taken a sign of successful lumbar epidural block.

详细描述

The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia/anesthesia for childbirth (vaginal and cesarean delivery) in women with a BMI greater than 30 kg/m2.

研究设计

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

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients requesting epidural analgesia/anesthesia for childbirth
  • American Society of Anesthesiologists (ASA) physical status I to III
  • Ability to speak and read English to fully comprehend the consent process
  • BMI greater than 30 kg/m2

排除标准

  • Combined spinal-epidural anesthesia
  • Coagulopathy
  • History of lumbar spine surgery
  • Allergy or contraindication to any of the study medications
  • Contraindication to epidural analgesia
  • ASA physical status >III
  • BMI less than 30 kg/m2

结局指标

主要结局

Measure of bilateral decrease of sensation to cold with ice

时间窗: 30 Minutes Post Intervention

Loss of sensation to ice; Following epidural procedure, subjects will be assessed to see if their epidural analgesia is working by determining if they have hyperthesia to ice on lower abdomen.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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