Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT05201261
Status:
UNKNOWN
Last Update Posted:
2022-01-21
First Post:
2021-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Relationship Between Vertebral Body Length, Subarachnoid Space Width and Block Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2021-12-16', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The length of lumbar cone', 'timeFrame': '1year', 'description': 'Ultrasound findings'}, {'measure': 'The width of subarachnoid space was measured by ultrasound', 'timeFrame': '1year', 'description': 'Ultrasound findings'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Combined Spinal Epidurai Anesthesia', 'Lower Extremity Surgery']}, 'descriptionModule': {'briefSummary': "Spinal anesthesia technology has been widely used in various surgeries and multi-mode analgesia. Spinal ultrasound imaging has been proved to be a reliable tool for evaluating spinal parameters. Ultrasound-guided spinal puncture technology has also been skillfully applied in clinical practice. How to provide perfect nerve block effect for operation, provide good postoperative analgesia, and prevent unnecessary extensive block leading to other complications and related risks has always been the focus of anesthesiologists. Doses and the relationship between the anesthesia plane great individual differences, and previous research on the patient's own condition such as height, weight, 6 to the anesthesia plane have different results, the influence of clinical work often refer patients height adjustment of drug doses, this research attempts to evaluate ultrasound was used to assess spinal vertebral body in the plane of the length and width of subarachnoid and anesthesia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective surgery under spinal anesthesia. Inclusion criteria: (1) Elective lower extremity surgery; (3) ASA (American Society of Anesthesiologists) Grading: ⅰ - ⅲ.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective lower limbs surgery\n* ASA: grade I to III\n\nExclusion Criteria:\n\n* There are contraindications to spinal anesthesia\n* Allergic to local anesthetics\n* Patient refused'}, 'identificationModule': {'nctId': 'NCT05201261', 'briefTitle': 'the Relationship Between Vertebral Body Length, Subarachnoid Space Width and Block Level', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'the Relationship Between Vertebral Body Length, Subarachnoid Space Width and Block Level', 'orgStudyIdInfo': {'id': 'block level'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ultrasound-guided group', 'description': 'Adult patients with American Society of Anesthesiologists physical status I/II/III scheduled to undergo elective Lower limb surgery under spinal anesthesia were considered for eligibility.', 'interventionNames': ['Device: ltrasonic measure']}], 'interventions': [{'name': 'ltrasonic measure', 'type': 'DEVICE', 'description': 'In the right decubitus position, the spine was scanned with an ultrasonic convex array probe. Starting from the sacrum, the length of each vertebral body of the lumbar spine was measured on a para-midsagittal oblique view. The intervertebral space was located and the width of the subarachnoid space was measured on a midsagittal and transverse view.', 'armGroupLabels': ['Ultrasound-guided group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Yanchao Yang', 'investigatorAffiliation': 'Shengjing Hospital'}}}}