Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04861935
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2021-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups were formed as those with and without dimples in the sacral region.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2021-04-24', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ultrasound measurement-1', 'timeFrame': '1 min', 'description': 'Dural sac level (mm)'}, {'measure': 'ultrasound measurement-2', 'timeFrame': '1 min', 'description': 'distance between injection site and dural sac(mm)'}, {'measure': 'ultrasound measurement-3', 'timeFrame': '1 min', 'description': 'optimal entry angle (0-angle degree) for caudal block'}], 'secondaryOutcomes': [{'measure': 'ultrasound evaluation of sacral region', 'timeFrame': '10 minutes', 'description': 'searching for spinal abnormalites in patients with sacral dimple'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric, sacral dimple, ultrasound'], 'conditions': ['Sacrococcygeal Disorder']}, 'referencesModule': {'references': [{'pmid': '21981093', 'type': 'BACKGROUND', 'citation': 'Schwartz D, Al-Najjar H, Connelly NR. Caudal block in a child with a sacral dimple utilizing ultrasonography. Paediatr Anaesth. 2011 Oct;21(10):1073-4. doi: 10.1111/j.1460-9592.2011.03621.x. No abstract available.'}, {'pmid': '29963103', 'type': 'BACKGROUND', 'citation': 'Choi JH, Lee T, Kwon HH, You SK, Kang JW. Outcome of ultrasonographic imaging in infants with sacral dimple. Korean J Pediatr. 2018 Jun;61(6):194-199. doi: 10.3345/kjp.2018.61.6.194. Epub 2018 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'When dimples are detected in the sacral region, most practitioners consider it to be a sign of spinal anomaly and avoid caudal block. Ultrasound guided investigation of the anatomical features for caudal block in normal children and in children with sacral dimple will be informative for practitioners.', 'detailedDescription': 'A dimple over the sacrum may be an isolated finding or a sign of underlying spinal abnormality. Therefore, most practitioners are confused to perform a caudal block. Ultrasonography is a safe and cost effective screening tool in pediatric patients. Ultrasound guided investigation of the anatomical features of sacral region may play a key role to eliminate suspicions. It is possible to detect spinal abnormalities and also measuring dural sac level, distance between dural sac and estimated needle insertion site or needle entry angle. In this study, we will examine whether there is a difference between normal children and children with dimple in the sacral region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Months', 'minimumAge': '1 Month', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Children aged 1-72 months who are taken to the operating room for any reason\n\nExclusion Criteria: Patients with\n\n* spinal anomalies,\n* history of prematurity,\n* neurological disorder\n* syndromic illness.'}, 'identificationModule': {'nctId': 'NCT04861935', 'briefTitle': 'Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple', 'orgStudyIdInfo': {'id': '72109855-604.01.01-231115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'ultrasound evaluation of sacral region in normal pediatric patients', 'description': 'Ultrasound evaluation of sacral region will be performed to detect spinal abnormality.\n\nDural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured.', 'interventionNames': ['Device: ultrasound evaluation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ultrasound evaluation of sacral region in patients with sacral dimple', 'description': 'Ultrasound evaluation of sacral region will be performed to detect spinal abnormality.\n\nDural sac level and its distance to estmated injection site, optimal entry angle for caudal block will be measured.', 'interventionNames': ['Device: ultrasound evaluation']}], 'interventions': [{'name': 'ultrasound evaluation', 'type': 'DEVICE', 'description': 'ultrasound evaluation of normal patients and patients who have a sacral dimple', 'armGroupLabels': ['ultrasound evaluation of sacral region in normal pediatric patients', 'ultrasound evaluation of sacral region in patients with sacral dimple']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Guner Kaya, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD', 'investigatorFullName': 'Celal Kaya', 'investigatorAffiliation': 'Istanbul University'}}}}