Ultrasound Imaging For Facilitating Labour Epidurals in Obese Parturients

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Ultrasound

Detailed Description

Recent technical advances, especially the evolution of ultrasound technology, have helped to some extent in circumventing some of the limitations of epidural anesthesia. 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 are the most challenging group for the identification of anatomical landmarks, it is important to determine if ultrasound imaging is a useful technique in this population.

All the patients will undergo ultrasound imaging of the lumbar spine just before epidural insertion. Ultrasound imaging will be performed by one of the investigators. A different anesthesiologist will perform the epidural procedure based on the US information provided by the investigator. The investigator will provide information to the epidural performer on the insertion point, the angle of needle insertion and safe approximate distance before reaching the epidural space to facilitate the epidural performance. To maintain blinding and to prevent performer bias, the exact depth of the epidural space from skin, as seen on the ultrasound will not be disclosed. The investigator, with the aid of an in-built caliper, will measure this distance at a later time before saving the image.

The results of this study are expected to determine the clinical reliability of ultrasound imaging in visualizing the anatomical structures relevant to the technical performance of epidural analgesia in the obese population. Since technical difficulty in performing epidurals is more commonly encountered in obese patients, ultrasound visualization would improve the overall success of the technique by predicting the depth of the epidural needle to be inserted. In turn, the complication rate would be minimized.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Accuracy of Epidural Depth	30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Investigators: Principal Investigator: Mrinalini Balki, MD, Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: February 22, 2007
• First Submitted That Met QC Criteria: February 22, 2007
• First Posted (Estimate): February 26, 2007

Study Record Updates

• Last Update Posted (Estimate): July 30, 2009
• Last Update Submitted That Met QC Criteria: July 29, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Ultrasound; Obesity; Needle Depth
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 06-03; 06-0218-E