Three-Dimensional Ultrasound (3D US) in Parturients

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523249
• Other study ID #: H10-01974
• Status: Completed
• Phase: N/A
• First received: January 27, 2012
• Last updated: September 26, 2014
• Start date: November 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Distance between needle insertion point and spine midline	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.	20 minutes of testing prior to delivery
Secondary	assess quality of 3D US images	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.	one year