Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 2:40 AM
Study NCT ID:
NCT01409460
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2011-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obturator Nerve Block With Femoral and Sciatic Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2011-08-02', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the use of obturator Nerve block for patients undergoing total knee arthroplasty', 'timeFrame': '15 minutes in recovery room post operatively', 'description': 'The need for rescue obturator nerve block in total knee arthoplasty patients who have sucessful femoral nerve block and sciatic nerve block in place.'}], 'secondaryOutcomes': [{'measure': 'Pain medication use intra-operatively and in the recovery room after surgery. Pain scores in recovery room.', 'timeFrame': 'During surgery and until discharge from recovery room.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nerve Block; Pain Medication']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how many patients require the addition of the obturator nerve block in the recovery room after the total knee surgery. Also to study the efficacy of blocking the obturator nerve in controlling their knee pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* total knee replacement\n\nExclusion Criteria:\n\n* Hisory of neurologica disease, diabetes, pregnancy, neuropathy'}, 'identificationModule': {'nctId': 'NCT01409460', 'briefTitle': 'Obturator Nerve Block With Femoral and Sciatic Block', 'organization': {'class': 'OTHER', 'fullName': 'Trinity Health Of New England'}, 'officialTitle': 'Is an Obturator Nerve Block Required for Every Patient Having Total Knee Arthroplasty With Femoral and Sciatic Nerve Block?', 'orgStudyIdInfo': {'id': '08-10-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'True Obturator Nerve Block', 'interventionNames': ['Procedure: Oburator Nerve block']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Block', 'interventionNames': ['Procedure: Sham Injection in pectineus muscle.']}], 'interventions': [{'name': 'Oburator Nerve block', 'type': 'PROCEDURE', 'description': 'Use of selective pain block.', 'armGroupLabels': ['True Obturator Nerve Block']}, {'name': 'Sham Injection in pectineus muscle.', 'type': 'PROCEDURE', 'description': 'Five minutes after the sham block pain was assessed in these patients. If pain score was 5 or greater a true obturator nerve block was performed on these patients.', 'armGroupLabels': ['Sham Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06105', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Saint Francis Hospital and Medical Center', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trinity Health Of New England', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sanjay Sinha', 'oldOrganization': 'Saint Francis Hospital'}}}}