Ultrasound Imaging For Facilitating Labour Epidurals in Obese Parturients

NCT00439998 | Completed

• 2 other identifiers: 06-0306-0218-E
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy of an epidural depends mainly on accurate placement of the catheter in the epidural space. Therefore, identification of the epidural space is the most vital part of the procedure. Obese patients represent the most challenging group for the identification of anatomical landmarks. With the use of ultrasound, we can visualize the images of the anatomical structures in the back. Some anesthesiologists believe ultrasound can help in the placement of an epidural, and routinely use it to assist in determining needle entry point in your back as well as estimating the depth at which the epidural space will be found. Our hypothesis is that the use of lumbar spine ultrasound imaging will accurately determine the epidural space depth and the epidural insertion point in obese patients.

Conditions

Obesity

Keywords

Ultrasound; Obesity; Needle Depth

Outcome Measures

Primary Outcomes (1)

• Accuracy of Epidural Depth

  30 minutes

Secondary Outcomes (4)

• Accuracy of needle angle, re-insertion of the epidural needle in the same interspace or different interspace

  30 minutes

• Correlation between BMI and skin thickness

  analysis at study end, approximately 1 year

• Correlation between BMI and needle depth

  analysis at study end, approximately 1 year

• Duration of ultrasound scanning

  30 minutes

Interventions

Ultrasound PROCEDURE

ultrasound scan of the lumbar spine with 2-5 MHz curved array probe

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Full term pregnant patients requesting labor epidurals
• Pre-pregnancy BMI greater than 30

You may not qualify if:

• Known spinal deformities
• Previous back instrumentation
• Pre-pregnancy BMI less than 30

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Mrinalini Balki, MD

  Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 26, 2007
• Study Start: October 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 30, 2009

Record last verified: 2009-07

Locations

CA (1)