Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-03-02 @ 8:19 AM
Study NCT ID:
NCT02281227
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2014-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of a Proper Needle Entry Point; Effects of Skin Compression With an Indicator on Radiation Exposure Time of Fluoroscopically Guided Transforaminal Epidural Block in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2015-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-21', 'studyFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2014-10-29', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total radiation exposure time', 'timeFrame': 'immediately ≤1 sec after the confirmation of successful epidural injection', 'description': 'Total radiation exposure time during whole epidural procedure.'}], 'secondaryOutcomes': [{'measure': 'The number of the needle readjustments', 'timeFrame': 'immediately ≤1 sec after the confirmation of successful epidural injection', 'description': 'The number of the needle readjustments for successful epidural injection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Low Back Pain Due to Spinal Nerve Compression']}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of skin compression with an indicator at the needle entry point on radiation exposure time of fluoroscopically guided transforaminal epidural block in obese patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with ≥ 25 kg/m2 BMI who were scheduled for the transforaminal epidural injection\n\nExclusion Criteria:\n\n* Local anesthetic allergy, coagulopathy'}, 'identificationModule': {'nctId': 'NCT02281227', 'briefTitle': 'Determination of a Proper Needle Entry Point; Effects of Skin Compression With an Indicator on Radiation Exposure Time of Fluoroscopically Guided Transforaminal Epidural Block in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2014-0721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'compression group', 'description': 'skin compression with an indicator for determination of needle entry point', 'interventionNames': ['Procedure: skin compression']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-compression group', 'description': 'non skin compression with an indicator for determination of needle entry point', 'interventionNames': ['Procedure: skin compression']}], 'interventions': [{'name': 'skin compression', 'type': 'PROCEDURE', 'description': 'skin compression with an indicator for determination of needle entry point', 'armGroupLabels': ['compression group', 'non-compression group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}