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

NCT ID: NCT01352806

Last Updated: 2011-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Accuracy of Identifying the Intralaminar Space

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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fluoroscopy, palpation, ultrasound

in the same subject we will compare the accuracy of identifying the intralaminar space by three technique, fluoroscopy, ultrasound, palpation.

Group Type EXPERIMENTAL

identification of the lumbar interspinous space using fluoroscopy versus ultrasound versuspalpation

Intervention Type PROCEDURE

Copmarison of multiple technique for identification of the lumbar interspinous space,which is fluoroscopy,ultrasound and palpation

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Orginization

Principal Investigators

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Fayez Saifi, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Fayez Saifi, MD

Role: CONTACT

00 972 508946127

Hadas Lemberg, PhD

Role: CONTACT

00 972 2 6777572

Facility Contacts

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Arik Tzukert, DMD

Role: primary

00 972 2 6776095

Hadas Lemberg, PhD

Role: backup

00 972 2 6777572

Other Identifiers

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039910-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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