Real-time Ultrasound-guided Paramedian Epidural Access: Evaluation of a Novel In-plane Transverse View Technique
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|ClinicalTrials.gov Identifier: NCT01686243|
Recruitment Status : Recruiting
First Posted : September 18, 2012
Last Update Posted : November 6, 2017
The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk TuohySono"
The investigators believe that this new technique is helpful to get the best anatomic landmark for epidural catheter placement using the real-time ultrasound.
- Block performance time.
- Block success rate.
- Needle Depth to epidural space
Block success rate will be measured as the rate of cases that will have successful insertion of the epidural catheter using ultrasound guidance and the case is done completely under epidural anesthesia.
All cases that will be converted to general anesthesia will be counted unsuccessful.
Other measurable outcome data that will be collected will include needle depth to the epidural space, and ultrasound measured depth to the lamina
|Condition or disease||Intervention/treatment||Phase|
|Epidural Placement||Other: epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono) Other: standard epidural placement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: echogenic 17G tuohy needles " Pajunk TuohySono
Epidural will be placed with the aid of ultrasound and echogenic 17G Tuohy needles (Pajunk TuohySono).
Other: epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)
Anesthesiologist will place epidural with aid of ultrasound and placement with echogenic 17G Tuohy needles (Pajunk TuohySono)
Placebo Comparator: standard epidural needles
Epidural will be placed in standard practice with standard needles.
Other: standard epidural placement
Anesthesiologist will place epidural within standard practice, with standard needles.
- feasibility [ Time Frame: Day 1 ]The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk TuohySono"
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686243
|Contact: Sherif Zaky, M.D.||email@example.com|
|Contact: Roberta Johnsonfirstname.lastname@example.org|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Sherif Zaky, M.D. 216-445-1072 email@example.com|
|Principal Investigator:||Sherif Zaky, M.D.||The Cleveland Clinic|