跳至主要内容
临床试验/NCT01523249
NCT01523249已完成不适用

Three-Dimensional Ultrasound (3D US) for Epidural Needle Insertion in Parturients

University of British Columbia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Distance between two needle insertion points

研究概览

简要总结

The purpose of this study is to compare accuracy of a new three-dimensional ultrasound (3D US) technique with the traditional palpation method for identification of the needle insertion site on patients' skin before epidural needle placement in pregnant women. The investigators hypothesize that the needle puncture site identified by 3D US is located within a 5 mm radius from the puncture site identified by palpation.

详细描述

Traditionally, the manual palpation of lower back is used to identify the skin insertion point for the epidural needle placement in obstetric patients. Recently, two-dimensional ultrasound (2D US) scanning before the epidural needle insertion proved to improve an accurate determination of inter-vertebral levels and spine midline. 2D US is also useful in determining the depth to the epidural space and needle insertion angle. A three-dimensional ultrasound (3D US) technique is a new advancement in the ultrasound technology. 3D US allows for a real-time, visual guidance of the epidural needle insertion. This study will assess weather 3D US, compared to palpation, can accurately identify the skin needle insertion site for the epidural needle placement.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • ASA I or II
  • Greater than or equal to 19 years old
  • Term pregnancy (greater than or equal to 38 weeks gestation age)
  • Ability to read English in order to understand the consent form

排除标准

  • BMI greater than or equal to 40
  • Scoliosis
  • Previous difficult regional anesthesia/analgesia
  • Previous lower back surgery
  • Active labour
  • Allergy to epidural tape, surgical paper tape, or felt pen

结局指标

主要结局

Distance between two needle insertion points

时间窗: 20 minutes of testing prior to delivery

To measure the distance between the needle puncture site identified by the 3D US transducer to the needle puncture site identified by palpation, measured on a transparency film.

次要结局

  • assess quality of 3D US images(one year)
  • Distance between needle insertion point and spine midline(20 minutes of testing prior to delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验