Ultrasound Imaging For Facilitating Labour Epidurals in Obese Parturients
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|ClinicalTrials.gov Identifier: NCT00439998|
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : July 30, 2009
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Procedure: Ultrasound||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultrasound Imaging For Facilitating Labour Epidurals in Obese Parturients|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
- Accuracy of Epidural Depth [ Time Frame: 30 minutes ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439998
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Mrinalini Balki, MD||Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto|