Identification of the Lumbar Interspinous Spaces; Palpation Versus Ultrasound Versus Fluoroscopy

Accuracy of Identifying the Intralaminar Space Clinical Trial

Official title:

Identification of the Lumbar Interspinous Spaces; Palpation Versus Ultrasound Versus Fluoroscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01352806
• Other study ID #: 039910-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: April 27, 2011
• Last updated: May 11, 2011
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2011
• Source: Hadassah Medical Organization
• Contact: Fayez Saifi, MD
• Phone: 00 972 508946127
• Email: saififayez[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient scheduled for epidural steroid injection under fluoroscopy technique.

• Age above 18 years

Exclusion Criteria:

• Inability to understand consent form.

• refusing to sign the consent form.

• contraindication for neuraxial injection.

• local or systemic infection.

• pregnant women.

• previous spine surgery.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Accuracy of Identifying the Intralaminar Space

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem 91120

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of identifying the intralaminar space		one year	No
Secondary	Patient satisfaction		one year	No