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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Three-Dimensional Ultrasound (3D US) for Epidural Needle Insertion in Parturients|
- 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.
- 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.
|Study Start Date:||November 2013|
|Study Completion Date:||September 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523249
|Canada, British Columbia|
|BC Women's Hospital|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Principal Investigator:||Allaudin Kamani, MD||University of British Columbia and BC Women's Hospital|