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

H

Hadassah Medical Center

Status

Unknown

Conditions

Accuracy of Identifying the Intralaminar Space

Treatments

Procedure: identification of the lumbar interspinous space using fluoroscopy versus ultrasound versuspalpation

Study type

Interventional

Funder types

Other

Identifiers

NCT01352806
039910-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

fluoroscopy, palpation, ultrasound
Experimental group
Description:
in the same subject we will compare the accuracy of identifying the intralaminar space by three technique, fluoroscopy, ultrasound, palpation.
Treatment:
Procedure: identification of the lumbar interspinous space using fluoroscopy versus ultrasound versuspalpation

Trial contacts and locations

1

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Central trial contact

Fayez Saifi, MD; Hadas Lemberg, PhD

Data sourced from clinicaltrials.gov

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