Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-28 @ 1:40 PM
Study NCT ID:
NCT04039295
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2019-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Injection Volume for Caudal Epidural Block Using Dynamic US Imaging in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-15', 'studyFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2019-07-29', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Required volume of local anesthetics', 'timeFrame': '1 day', 'description': 'Required volume of local anesthetics to reach each level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caudal Epidural Block']}, 'referencesModule': {'references': [{'pmid': '37429622', 'type': 'DERIVED', 'citation': 'Kim HJ, Kim H, Lee S, Koh WU, Park SS, Ro Y. Reconsidering injection volume for caudal epidural block in young pediatric patients: a dynamic flow tracking experimental study. Reg Anesth Pain Med. 2024 May 7;49(5):355-360. doi: 10.1136/rapm-2023-104409.'}]}, 'descriptionModule': {'briefSummary': 'Caudal epidural block is the most commonly used technique for analgesia in pediatric patients. Although there are clinically used doses of local anesthetics for caudal epidural block, we do not know exactly how much levels are blocked in young children. Thus, we aimed to identify the spreading of injection of local anesthetics for caudal epidural block using ultrasound imaging in young children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Among the patients who are scheduled to undergo elective polydactyly / syndactyly / polysyndactyly correction surgery in Asan Medical Center, the patients who meet the inclusion criteria are included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 6-24months\n* ASA 1-3\n* body weight: 5-20kg\n\nExclusion Criteria:\n\n* patients who refuse to participate\n* local site infection, pilonidal cyst, spina bifida\n* spinal/meningeal abnormality\n* patients who discharge after surgery without admission\n* patients who is judged ineligible for other reasons by the authors'}, 'identificationModule': {'nctId': 'NCT04039295', 'briefTitle': 'Estimation of Injection Volume for Caudal Epidural Block Using Dynamic US Imaging in Children', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Estimation of Injection Volume for Caudal Epidural Block Using Dynamic Ultrasound Imaging in Young Pediatric Patients: an Observational Study', 'orgStudyIdInfo': {'id': '2019-0750'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ultrasound guided caudal epidural block', 'type': 'PROCEDURE', 'description': 'dynamic ultrasound imaging of the spread of local anesthetics'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyungtae Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical instructor', 'investigatorFullName': 'Hajung Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}