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Three-Dimensional Ultrasound (3D US) in Parturients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01523249
Enrollment
20
Registered
2012-02-01
Start date
2013-11-30
Completion date
2014-09-30
Last updated
2014-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

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

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.

Interventions

DEVICELumbar 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.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University of British Columbia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Distance between two needle insertion points20 minutes of testing prior to deliveryTo 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

MeasureTime frameDescription
Distance between needle insertion point and spine midline20 minutes of testing prior to deliveryTo 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 imagesone yearTo 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026