Three-Dimensional Ultrasound (3D US) in Parturients

NCT01523249 | Completed

• 1 other identifier: H10-01974
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

3D ultrasonography; epidural; neuraxial anesthesia; neuraxial analgesia; pregnant woman; parturients

Outcome Measures

Primary Outcomes (1)

• Distance between two needle insertion points

  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.

  20 minutes of testing prior to delivery

Secondary Outcomes (2)

• Distance between needle insertion point and spine midline

  20 minutes of testing prior to delivery

• assess quality of 3D US images

  one year

Study Arms (1)

Scanned and palpated

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

Device: Lumbar 3D ultrasound scanning and palpation (Ultrasonix )

Interventions

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.

Also known as: Ultrasonix US machine (model Sonix Touch)

Scanned and palpated

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Term pregnant women expecting neuraxial anesthesia or analgesia for cesarean delivery or labour pain control at BC Women's Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Interventions

Palpation

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Allaudin Kamani, MD

  University of British Columbia and BC Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 1, 2012
• Study Start: November 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

CA (1)