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

May 11, 2011 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem 91120, Israel, POB 12000
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
accuracy of identifying the intralaminar space
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Fayez Saifi, MD, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Estimate)

May 12, 2011

Last Update Submitted That Met QC Criteria

May 11, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 039910-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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