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Three-Dimensional Ultrasound (3D US) in Parturients

NCT ID: NCT01523249

Last Updated: 2014-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Pregnancy

Keywords

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3D ultrasonography epidural neuraxial anesthesia neuraxial analgesia pregnant woman parturients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Scanned and palpated

Healthy, pregnant, term women delivering at BC Women's Hospital and expecting to have neuraxial anesthesia.

Lumbar 3D ultrasound scanning and palpation (Ultrasonix )

Intervention Type 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.

Interventions

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Lumbar 3D ultrasound scanning and palpation (Ultrasonix )

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.

Intervention Type DEVICE

Other Intervention Names

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Ultrasonix US machine (model Sonix Touch)

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allaudin Kamani, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia and BC Women's Hospital

Locations

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BC Women's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H10-01974

Identifier Type: -

Identifier Source: org_study_id