Identification of the Lumbar Interspinous Spaces; Palpation Versus Ultrasound Versus Fluoroscopy
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|ClinicalTrials.gov Identifier: NCT01352806|
Recruitment Status : Unknown
Verified April 2011 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : May 12, 2011
Last Update Posted : May 12, 2011
The of epidurals and spinals, relies primarily on palpation of anatomic landmarks that are not always easy to find, More so, even after correct identification of palpable landmarks, Variability exists leading to performing neuraxial injection in undetermined intralaminar level. The most accurate method for identifying the interspace is the using of the fluoroscopy or CT technique, but exposure to radiation and availability make it unpractical in majority of cases. As ultrasound technology becomes more accessible to the clinician, it holds great potential to facilitate performing neuraxial anesthesia by the anesthesiologist in routine cases.
The aim of this study to compare the accuracy of identifying the intervertebral space, between manual palpation, versus ultrasound versus fluoroscopy.
|Condition or disease||Intervention/treatment||Phase|
|Accuracy of Identifying the Intralaminar Space||Procedure: identification of the lumbar interspinous space using fluoroscopy versus ultrasound versuspalpation||Not Applicable|
Neuraxial anesthesia relies upon a sound knowledge of anatomy to accurately direct needle placement both to achieve consistent success, and to avoid damage to other nearby structures. This prospective randomized study, will be performed in the pain management unit. We will assess patients who are scheduled to receive an epidural steroid injection. The investigator will request permission fro the ethics committee of Hadassah Medical Hospital.
Three anesthesiologist will perform this study, every one of the anesthesiologist will be asked to identify intralaminar space by one technique and we will compare the accuracy of the identifying of the intralaminar space.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Identification of the Lumbar Interspinous Spaces; Palpation Versus Ultrasound Versus Fluoroscopy|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||December 2012|
Experimental: fluoroscopy, palpation, ultrasound
in the same subject we will compare the accuracy of identifying the intralaminar space by three technique, fluoroscopy, ultrasound, palpation.
Procedure: identification of the lumbar interspinous space using fluoroscopy versus ultrasound versuspalpation
Copmarison of multiple technique for identification of the lumbar interspinous space,which is fluoroscopy,ultrasound and palpation
- accuracy of identifying the intralaminar space [ Time Frame: one year ]
- Patient satisfaction [ Time Frame: one year ]
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): NCT01352806
|Contact: Fayez Saifi, MD||00 972 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD||00 972 2 email@example.com|
|Hadassah Medical Organization||Not yet recruiting|
|Jerusalem 91120, Israel, POB 12000|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 email@example.com|
|Principal Investigator: Fayez T Saifi, MD|
|Principal Investigator:||Fayez Saifi, MD||Hadassah Medical Organization|