Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2025-12-30 @ 5:28 AM
Study NCT ID:
NCT03678961
Status:
COMPLETED
Last Update Posted:
2018-12-20
First Post:
2018-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Leg Position on the Sciatic Nerve on Sonogram
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-19', 'studyFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2018-09-19', 'lastUpdatePostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visibility of sciatic nerve', 'timeFrame': 'during 10 minutes of anesthesia induction', 'description': 'Visibility of sciatic nerve at each position assessed using a scoring system (0, no nerve identified; 1, nerve identified with a high probability; 2, nerve identified, but most of it not visible; 3, nerve identified, more than 50% of its borders can be precisely distinguished from surrounding structures; 4, nerve completely visible, but fascicles poorly defined; 5, nerve completely visible and multiple fascicles identifiable.)'}], 'secondaryOutcomes': [{'measure': 'Depth of sciatic nerve', 'timeFrame': 'during 10 minutes of anesthesia induction', 'description': 'Distance from skin to sciatic nerve at each position'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sciatic Nerve Block']}, 'descriptionModule': {'briefSummary': 'Little is known about which posture of lower extremity makes it easier to access to the sciatic nerve. In this study, the investigators aimed to identify the most appropriate positioning of the lower extremity during anterior-approach ultrasound-guided sciatic nerve block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing knee surgery requiring peripheral nerve block', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA PS 1-3\n* patients undergoing knee surgery requiring peripheral nerve block\n\nExclusion Criteria:\n\n* patients who refuse to participate in the study\n* BMI \\> 40 kg/m2\n* patients who have congenital abnormality on leg\n* patients who have surgery or trauma on hip/knee\n* patients who cannot move freely due to the contracture\n* patients who are judged ineligible by the medical staff to participate in the study for other reasons'}, 'identificationModule': {'nctId': 'NCT03678961', 'briefTitle': 'The Effect of Leg Position on the Sciatic Nerve on Sonogram', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Influence of Lower Extremity Positioning During Anterior-approach Ultrasound-guided Sciatic Nerve Block: Depth and Visibility', 'orgStudyIdInfo': {'id': '2018-0970'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group N', 'description': 'Neutral position'}, {'label': 'Group E', 'description': 'External rotation of leg by 45 degrees', 'interventionNames': ['Behavioral: external rotation of leg']}, {'label': 'Group EF45', 'description': 'External rotation of leg by 45 degrees, hip flexion by 45 degrees, and knee flexion by 45 degrees', 'interventionNames': ['Behavioral: external rotation of leg', 'Behavioral: hip flexion and knee flexion']}, {'label': 'Group EF15', 'description': 'External rotation of leg by 45 degrees, hip flexion by 15 degrees, and knee flexion by 15 degrees', 'interventionNames': ['Behavioral: external rotation of leg', 'Behavioral: hip flexion and knee flexion']}], 'interventions': [{'name': 'external rotation of leg', 'type': 'BEHAVIORAL', 'description': 'external rotation of leg by 45 degrees', 'armGroupLabels': ['Group E', 'Group EF15', 'Group EF45']}, {'name': 'hip flexion and knee flexion', 'type': 'BEHAVIORAL', 'description': 'hip flexion by 15/45 degrees and knee flexion by 15/45 degrees', 'armGroupLabels': ['Group EF15', 'Group EF45']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Uk Koh, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulsan, College of Medicine, Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Instructor', 'investigatorFullName': 'Hajung Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}