Three-Dimensional Ultrasound (3D US) in Parturients

Completed

• Conditions: Pregnancy
• Interventions: Device: Lumbar 3D ultrasound scanning and palpation (Ultrasonix )

• Registration Number: NCT01523249
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-01
• Study Start: 2013-11
• Primary Completion: 2014-02
• Status Verified: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-26
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Scanned and palpated	Lumbar 3D ultrasound scanning and palpation (Ultrasonix )	Healthy, pregnant, term women delivering at BC Women's Hospital and expecting to have neuraxial anesthesia.

Primary Outcome Measures

Name	Time	Method
Distance between two needle insertion points	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 Outcome Measures

Name	Time	Method
assess quality of 3D US images	one year	To obtain US images of the epidural anatomy with various settings of the image-processing system to determine the optimal 3D US parameters that give the clearest images. An experienced sonographer will analyze the US images in the UBC laboratory using a qualitative measure of clarity (scale of 1 to 5) of the depiction of the ligamentum flavum and laminae. This quality measure will be correlated to the image acquisition parameters to determine the optimal set of parameters.
Distance between needle insertion point and spine midline	20 minutes of testing prior to delivery	To measure the perpendicular distance between the needle puncture site identified by the 3D US transducer to the midline identified by manual palpation (to the P-line), measured on a transparency film.

Trial Locations

Locations (1)

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada