Ultrasound Imaging For Facilitating Labour Epidurals in Obese Parturients - Full Text View

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

MedlinePlus related topics:

Obesity Obesity in Children Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Ultrasound Imaging For Facilitating Labour Epidurals in Obese Parturients

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 ]

Estimated Enrollment:	48
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2007

Intervention Details:

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

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

Contacts


Contact: Mrinalini Balki, MD	416-586-4800 ext 6268	mrinalini.balki@uhn.on.ca

Locations


Canada, Ontario
	Mount Sinai Hospital	Recruiting
	Toronto, Ontario, Canada, M5G 1X5
	Contact: Mrinalini Balki, MD 416-586-4800 ext 6268 mrinalini.balki@uhn.on.ca
	Sub-Investigator: Jose CA Carvalho, MD PhD
	Principal Investigator: Mrinalini Balki, MD
	Sub-Investigator: Yung Lee, MD
	Sub-Investigator: Stephen Halpern, MD

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

Study ID Numbers:	06-03, 06-0218-E
First Received:	February 22, 2007
Last Updated:	November 7, 2007
ClinicalTrials.gov Identifier:	NCT00439998
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Ultrasound

Obesity

Needle Depth

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Information provided by:	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:	NCT00439998