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Clinical Trials/NCT01523249
NCT01523249
Completed
Not Applicable

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

University of British Columbia1 site in 1 country20 target enrollmentNovember 2013
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
University of British Columbia
Enrollment
20
Locations
1
Primary Endpoint
Distance between two needle insertion points
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
September 2014
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Distance between two needle insertion points

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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