Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT01415193
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2011-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tibial Nerve Versus Sciatic Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2011-08-01', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess if selectively blocking only the tibial nerve component of the sciatic nerve will prevent foot drop.', 'timeFrame': 'Upon emergence from general anesthesia and up to 48 hours in the recovery room.', 'description': 'Measure frequency of foot drop in two groups and compare results.'}], 'secondaryOutcomes': [{'measure': 'To assess if levels of pain and analgesic requirements are similar between the two groups.', 'timeFrame': '24 hours after total knee replacement surgery.', 'description': 'Administer pain scale and monitor use of analgesics to compare levels two groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post Operative Analgesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyse the ability to selectively block the posterior tibial nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking the posterior tibial nerve will give the same post-operative pain relief after total knee surgery compared to a sciatic nerve block.'}, '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* History of neuralgia, diabetes, pregnancy, allergy to local anesthetic solutions'}, 'identificationModule': {'nctId': 'NCT01415193', 'briefTitle': 'Tibial Nerve Versus Sciatic Nerve Block', 'organization': {'class': 'OTHER', 'fullName': 'Trinity Health Of New England'}, 'officialTitle': 'Selective Tibial Nerve Block vs Popliteal Sciatic Nerve Block in Patients Having Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '09-02-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selective Tibial Nerve Block', 'interventionNames': ['Procedure: Selective Tibial Nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control: Sciatic Nerve Block', 'interventionNames': ['Procedure: Sciatic Nerve Block']}], 'interventions': [{'name': 'Selective Tibial Nerve block', 'type': 'PROCEDURE', 'description': 'Use of selective pain block.', 'armGroupLabels': ['Selective Tibial Nerve Block']}, {'name': 'Sciatic Nerve Block', 'type': 'PROCEDURE', 'description': 'Use of Sciatic Nerve Block', 'armGroupLabels': ['Control: Sciatic Nerve 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}}], 'overallOfficials': [{'name': 'Sanjay Sinha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Francis Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trinity Health Of New England', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}