A Prospective Evaluation of Iodinated Contrast Flow Patterns in Caudal Epidurography With Intentional Lateral Caudal Approach

April 18, 2011 updated by: Yonsei University
Caudal epidural block is useful not only for regional anesthesia of low abdominal, perineal area or lower extremities but for relieving acute or chronic pain of low back and lower extremities. Recently, there were some reports that there was a difference of the contrast flow pattern during lumbar epidural block according to a location of needle tip in the lumbar epidural space. Therefore, the investigators hypothesize that there is a difference of contrast flow pattern in caudal epidurography when a needle is inserted with intentionally lateral direction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

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

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

24

Description

Inclusion Criteria:

  • patients with unilateral radiculopathy

Exclusion Criteria:

  • patients with sepsis
  • chronic infection
  • coagulopathy
  • local infection near the sacral hiatus
  • the allergy of the contrast
  • history of spine surgery, scoliosis and kyphosis

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
intentional lateral caudal approach
Procedure: insertion needle via intentionally lateral direction.
evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A prospective evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach
Time Frame: during 10 seconds after obtaining the caudal epidurogram
Caudal epidural block is useful not only for regional anesthesia of low abdominal, perineal area or lower extremities but for relieving acute or chronic pain of low back and lower extremities. Recently, there were some reports that there was a difference of the contrast flow pattern during lumbar epidural block according to a location of needle tip in the lumbar epidural space. Therefore, the investigator hypothesizes that there is a difference of contrast flow pattern in caudal epidurography when a needle is inserted with intentionally lateral direction.
during 10 seconds after obtaining the caudal epidurogram

Collaborators and Investigators

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

Sponsor

Yonsei University

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

April 1, 2010

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

June 2, 2010

First Posted (ESTIMATE)

June 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 19, 2011

Last Update Submitted That Met QC Criteria

April 18, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2010-0016

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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