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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:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01136018
First received: May 26, 2010
Last updated: April 18, 2011
Last verified: April 2011
History of Changes
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136018

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

No publications provided

Responsible Party: Kyoung-bong Yoon, Anesthesiology in Severance hospital
ClinicalTrials.gov Identifier: NCT01136018     History of Changes
Other Study ID Numbers: 4-2010-0016
Study First Received: May 26, 2010
Last Updated: April 18, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on May 22, 2013