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临床试验/NCT03317626
NCT03317626已完成不适用

Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年9月20日最近更新:
适应症
干预措施

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
Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women.

研究概览

简要总结

Epidural analgesia for childbirth may fail to provide adequate pain relief. At NYULMC, to maximize the likelihood that epidural analgesia will work well, the gravity flow technique is used when performing epidural procedures.

The gravity flow technique is not well known, and is therefore used in only a few hospitals. 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 in laboring women.

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 in laboring women. This gravity flow technique was first described 26 years ago in 1991, and has been at NYU Langone for 15 years, since 2002. The technique has not been formally studied and this study is designed to enable assessment of the success rate of the gravity flow technique.

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 49 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Patients requesting epidural analgesia for labor
  • •ASA physical status I to II
  • •Ability to speak and read English to fully comprehend the consent process

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

研究组 & 干预措施

Cold Stimulus

Experimental

The study procedure will beto use a coldstimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen at 15 minutes and if necessary at 30 minutes after the epidural is inserted

干预措施: Cold Stimulus (ice) Test (Diagnostic Test)

结局指标

主要结局

Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women.

时间窗: 30 Minutes post intervention

Success will be defined as a bilateral decrease of sensation (hypesthesia) to cold and ice in at least 2 adjacent dermatomes between T8 and L2

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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