Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-31 @ 7:11 AM
Study NCT ID:
NCT01919658
Status:
TERMINATED
Last Update Posted:
2019-06-21
First Post:
2013-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Femoral vs Saphenous Nerve Blocks on Function After ACL Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009407', 'term': 'Nerve Block'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Difficulty enrolling, aim already examined in literature.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-19', 'studyFirstSubmitDate': '2013-08-06', 'studyFirstSubmitQcDate': '2013-08-07', 'lastUpdatePostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'strength of knee extensors', 'timeFrame': 'change from baseline preoperatively at 12 months', 'description': 'Extensor testing will be conducted in both legs using a hand held dynamometer.'}], 'secondaryOutcomes': [{'measure': 'pain level and functional outcomes', 'timeFrame': 'change from in hospital post-operative period at 12 months', 'description': 'Medical record will be reviewed for type and amount of in hospital post operative medication and levels, then assessed by PROMIS survey at follow up appointments.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nerve blocks in Anterior cruciate ligament surgery'], 'conditions': ['Anterior Cruciate Ligament']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to compare motor strength in knee extension between two groups of patients. One group receiving a proximal thigh block of the femoral nerve, and one receiving a distal thigh block of the saphenous nerve. The secondary objective is to compare the pain relief and functional outcomes in these two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-65\n2. Upcoming ACL reconstruction using patellar tendon autograft scheduled at Hershey Medical Center or the Hershey Outpatient Surgical Center (HOSC)\n\nExclusion Criteria:\n\n1. Documented neuropathy\n2. Skeletally immature\n3. Previous knee surgery\n4. Inability to provide informed consent\n5. ACL reconstruction with other tendon repairs'}, 'identificationModule': {'nctId': 'NCT01919658', 'briefTitle': 'Effects of Femoral vs Saphenous Nerve Blocks on Function After ACL Repair', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Effects of Femoral Versus Saphenous Nerve Blocks on Knee Extensor Strength, Pain, and Patient-Perceived Physical Function Following ACL Reconstruction', 'orgStudyIdInfo': {'id': 'IRB 42734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'proximal nerve block', 'description': 'The anesthesiologist will administer a proximal nerve block if specified in the randomization envelope.', 'interventionNames': ['Procedure: nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'distal nerve block', 'description': 'The anesthesiologist will administer a distal nerve block if specified in the randomization envelope.', 'interventionNames': ['Procedure: nerve block']}], 'interventions': [{'name': 'nerve block', 'type': 'PROCEDURE', 'description': 'A nerve block performed as per standard of care: femoral nerve blocks, and saphenous nerve blocks performed more distally (within 10cm superior to the adductor tubercle).', 'armGroupLabels': ['distal nerve block', 'proximal nerve block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Robert Gallo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert A. Gallo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Orthopaedic Surgery Sports Medicine', 'investigatorFullName': 'Robert A. Gallo', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}