Three-Dimensional Ultrasound (3D US) in Parturients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01523249
First received: January 27, 2012
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Three-Dimensional Ultrasound (3D US) for Epidural Needle Insertion in Parturients

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Distance between two needle insertion points [ Time Frame: 20 minutes of testing prior to delivery ] [ Designated as safety issue: No ]
    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:
  • Distance between needle insertion point and spine midline [ Time Frame: 20 minutes of testing prior to delivery ] [ Designated as safety issue: No ]
    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.

  • assess quality of 3D US images [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 )
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 Name: Ultrasonix US machine (model Sonix Touch)

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523249

Locations
Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Allaudin Kamani, MD University of British Columbia and BC Women's Hospital
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01523249     History of Changes
Other Study ID Numbers: H10-01974
Study First Received: January 27, 2012
Last Updated: May 26, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
3D ultrasonography
epidural
neuraxial anesthesia
neuraxial analgesia
pregnant woman
parturients

ClinicalTrials.gov processed this record on July 29, 2014