Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT01136018
Status:
COMPLETED
Last Update Posted:
2011-04-19
First Post:
2010-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Evaluation of Iodinated Contrast Flow Patterns in Caudal Epidurography With Intentional Lateral Caudal Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-18', 'studyFirstSubmitDate': '2010-05-26', 'studyFirstSubmitQcDate': '2010-06-02', 'lastUpdatePostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A prospective evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach', 'timeFrame': 'during 10 seconds after obtaining the caudal epidurogram', 'description': '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.'}]}, 'conditionsModule': {'conditions': ['Patient Who Needs Epidural Block']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '24', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with unilateral radiculopathy\n\nExclusion Criteria:\n\n* patients with sepsis\n* chronic infection\n* coagulopathy\n* local infection near the sacral hiatus\n* the allergy of the contrast\n* history of spine surgery, scoliosis and kyphosis'}, 'identificationModule': {'nctId': 'NCT01136018', 'briefTitle': 'A Prospective Evaluation of Iodinated Contrast Flow Patterns in Caudal Epidurography With Intentional Lateral Caudal Approach', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2010-0016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intentional lateral caudal approach', 'interventionNames': ['Procedure: insertion needle via intentionally lateral direction.']}], 'interventions': [{'name': 'insertion needle via intentionally lateral direction.', 'type': 'PROCEDURE', 'description': 'evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach', 'armGroupLabels': ['intentional lateral caudal approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kyoung-bong Yoon', 'oldOrganization': 'Anesthesiology in Severance hospital'}}}}