The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Anteroposterior Versus Oblique

July 24, 2014 updated by: Yonsei University
Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 TFESI between method in anteroposterior view and method in oblique view using Scotty dog, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.

Study Overview

Study Type

Interventional

Enrollment (Actual)

201

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

      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at our pain management clinic

Exclusion Criteria:

  • pregnancy
  • coagulopathy
  • systemic infection
  • any active infection at the injection site
  • history of allergy to contrast media, local anesthetics, corticosteroid
  • patients unable to communicate or patients with cognitive dysfunction

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anteroposterior approach group
anteroposterior approach group (n=104): check intravascular injection while performing S1 transforaminal epidural steroid injection in anteroposterior view under fluoroscopy
Active Comparator: oblique approach group
oblique approach group (n=104): same as anteroposterior approach group except using oblique view

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of intravascular injection
Time Frame: 5 seconds after injection of contrast media via block needle.
the incidence of intravascular injection in the anteroposterior approach group and the oblique approach group
5 seconds after injection of contrast media via block needle.

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

July 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 21, 2013

Study Record Updates

Last Update Posted (Estimate)

July 28, 2014

Last Update Submitted That Met QC Criteria

July 24, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2013-0310

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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