Ultrasound Imaging For Facilitating Labour Epidurals in Obese Parturients

This study has been completed.
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00439998
First received: February 22, 2007
Last updated: July 29, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention
Obesity
Procedure: Ultrasound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ultrasound Imaging For Facilitating Labour Epidurals in Obese Parturients

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Accuracy of Epidural Depth [ Time Frame: 30 minutes ]

Secondary Outcome Measures:
  • Accuracy of needle angle, re-insertion of the epidural needle in the same interspace or different interspace [ Time Frame: 30 minutes ]
  • Correlation between BMI and skin thickness [ Time Frame: analysis at study end, approximately 1 year ]
  • Correlation between BMI and needle depth [ Time Frame: analysis at study end, approximately 1 year ]
  • Duration of ultrasound scanning [ Time Frame: 30 minutes ]

Enrollment: 54
Study Start Date: October 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Ultrasound
    ultrasound scan of the lumbar spine with 2-5 MHz curved array probe
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439998

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00439998     History of Changes
Other Study ID Numbers: 06-03, 06-0218-E
Study First Received: February 22, 2007
Last Updated: July 29, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Ultrasound
Obesity
Needle Depth

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014