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NCT Number: NCT01523249

Three-Dimensional Ultrasound (3D US) in Parturients

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.

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Key information

Conditions

Pregnancy

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Primary location

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar 3D ultrasound scanning and palpation (Ultrasonix )

Device

Paramedian ultrasound scanning of L2-3 and L3-4 lumbar interspaces to visualize ligamentum flavum. Palpation of the same intervertebral spaces to identify spine midline and needle insertion point.

Other names: Ultrasonix US machine (model Sonix Touch)

Primary outcomes

  1. 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

  1. Distance between needle insertion point and spine midline

    Time frame: 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.

  2. assess quality of 3D US images

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2012
Registry last updated
Sep 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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