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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01352806
First received: April 27, 2011
Last updated: May 11, 2011
Last verified: April 2011
  Purpose

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 Intervention
Accuracy of Identifying the Intralaminar Space
Procedure: identification of the lumbar interspinous space using fluoroscopy versus ultrasound versuspalpation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Identification of the Lumbar Interspinous Spaces; Palpation Versus Ultrasound Versus Fluoroscopy

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • accuracy of identifying the intralaminar space [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352806

Contacts
Contact: Fayez Saifi, MD 00 972 508946127 saififayez@gmail.com
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem 91120, Israel, POB 12000
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Fayez T Saifi, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Fayez Saifi, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Dr. Saifi fayez, Hadassah Medical Orginization
ClinicalTrials.gov Identifier: NCT01352806     History of Changes
Other Study ID Numbers: 039910-HMO-CTIL
Study First Received: April 27, 2011
Last Updated: May 11, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
accuracy of identifying intralaminar space

ClinicalTrials.gov processed this record on August 28, 2014