Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-28 @ 8:31 PM
Study NCT ID:
NCT03753594
Status:
COMPLETED
Last Update Posted:
2019-05-13
First Post:
2018-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-10', 'studyFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2018-11-22', 'lastUpdatePostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regional tissue oxygenation saturation after successful femoral nerve block', 'timeFrame': 'at 5-minute intervals till 30 minutes after regional block', 'description': 'rSO2'}], 'secondaryOutcomes': [{'measure': 'Pinprick sensory scores', 'timeFrame': '5 minute before regional block and at 5-minute intervals till 30 minutes after regional block', 'description': 'A 3-level scale was used to grade the intensity of sensory block using pinprick stimulation: 0=normal sensation; 1=analgesia; 2=anesthesia.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral nerve block'], 'conditions': ['Anesthesia, Local']}, 'descriptionModule': {'briefSummary': 'Regional tissue oxygenation saturation has been shown to increase in innervated regions after sympathetic block. The aim of this prospective observational study was to evaluate the changes of regional tissue oxygenation saturation by near-infrared spectroscopy after successful femoral nerve block with ropivacaine and determine whether the changes of regional tissue oxygenation saturation can be affected by the concentration of ropivacaine.', 'detailedDescription': 'Successful peripheral nerve blocks induce sympathetic blockade, which increases local blood flow by vasodilation. The relationship between successful femoral nerve block and the variation of regional tissue oxygenation saturation was unclear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One hundred adult patients scheduled for elective knee arthroscopy with peripheral nerve block', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* American Society of Anesthesiologists physical statusⅠ-Ⅱ\n* Undergo elective elective knee arthroscopy with peripheral nerve block\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* BMI\\>35\n* Any contraindications to peripheral nerve block such as coagulation abnormalities, •Allergy to local anaesthetics, peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT03753594', 'briefTitle': 'Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block With Ropivacaine at Different Concentrations', 'orgStudyIdInfo': {'id': 'XH20181118'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'H group', 'description': 'Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.5% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests at 5 min were assessed before the block and at 5-min intervals till 30 min after the block.', 'interventionNames': ['Device: tissue oxygenation saturation']}, {'label': 'L group', 'description': 'Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.25% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests were assessed at 5 min before the block and at 5-min intervals till 30 min after the block.', 'interventionNames': ['Device: tissue oxygenation saturation']}], 'interventions': [{'name': 'tissue oxygenation saturation', 'type': 'DEVICE', 'description': 'tissue oxygenation saturation', 'armGroupLabels': ['H group', 'L group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Xiangdong Chen, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Department of Anesthesiology, Union Hospital of Tongji Medical College', 'investigatorFullName': 'Xi Wu', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}