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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136018
First Posted: June 3, 2010
Last Update Posted: April 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose
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.

Condition Intervention
Patient Who Needs Epidural Block Procedure: insertion needle via intentionally lateral direction.

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.


Enrollment: 22
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
24
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136018


Locations
Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Kyoung-bong Yoon, Anesthesiology in Severance hospital
ClinicalTrials.gov Identifier: NCT01136018     History of Changes
Other Study ID Numbers: 4-2010-0016
First Submitted: May 26, 2010
First Posted: June 3, 2010
Last Update Posted: April 19, 2011
Last Verified: April 2011