Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-31 @ 12:06 AM
Study NCT ID:
NCT05414604
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2022-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calculating the Volume of the Paravertebral Space
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2022-06-04', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lumbar paravertebral space', 'timeFrame': 'Baseline', 'description': 'Volume of the paravertebral space of the lumbar region'}, {'measure': 'Thoracic paravertebral space', 'timeFrame': 'Baseline', 'description': 'Volume of the paravertebral space of the thoracic region'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vertebral Disc Degenerative Disease']}, 'descriptionModule': {'briefSummary': 'Volume of the paravertebral spaces of the tharic and lumbar regions will be measured.', 'detailedDescription': 'Paravertebral block is an effective regional anesthesia method and a golden standart technique for various operations. In addition, paravertebral block is a volume dependent technique. However, there are few cadaveric studies that investigates the volume of the paravertebral space.\n\nThis study aims to calculate the volume of the paravertebral spaces of the lumbar and thoracic regions in the patients who had 3D computerized scan in Kocaeli University Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had a spine CT scan in our hospital due to vertebral disc degenerative disease', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had a CT scan of the spine in our hospital\n\nExclusion Criteria:\n\n* Patients with scoliosis or known vertebral abnormalities'}, 'identificationModule': {'nctId': 'NCT05414604', 'briefTitle': 'Calculating the Volume of the Paravertebral Space', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Calculating the Volume of the Paravertebral Space With 3D Computerized Tomography', 'orgStudyIdInfo': {'id': 'GOKAEK-2021/16.20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PV group', 'description': 'Patients who had a spine CT', 'interventionNames': ['Diagnostic Test: 3D spine CT']}], 'interventions': [{'name': '3D spine CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'CT scan of the spine', 'armGroupLabels': ['PV group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Principal investigator.', 'investigatorFullName': 'Can AKSU', 'investigatorAffiliation': 'Kocaeli University'}}}}