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

Not Applicable

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

• Registration Number: NCT01352806
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

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 Timeline

• Status Verified: 2011-04
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-05-11
• Last Update Submitted: 2011-05-11
• Study First Posted: 2011-05-12
• Last Update Posted: 2011-05-12
• Study Start: 2011-09
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fluoroscopy, palpation, ultrasound	identification of the lumbar interspinous space using fluoroscopy versus ultrasound versuspalpation	in the same subject we will compare the accuracy of identifying the intralaminar space by three technique, fluoroscopy, ultrasound, palpation.

Primary Outcome Measures

Name	Time	Method
accuracy of identifying the intralaminar space	one year

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	one year

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem 91120, Israel