Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-04-23 @ 7:49 AM
Study NCT ID:
NCT02495805
Status:
WITHDRAWN
Last Update Posted:
2016-12-09
First Post:
2015-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study never officially began- currently closed with IRB.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-08', 'studyFirstSubmitDate': '2015-06-30', 'studyFirstSubmitQcDate': '2015-07-08', 'lastUpdatePostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor effects', 'timeFrame': '24 hours (postoperatively)', 'description': "Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle."}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'On average between 6 and 8 hours postoperatively', 'description': "Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain."}, {'measure': 'Pain score', 'timeFrame': '24 hours (postoperatively)', 'description': "Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain."}, {'measure': 'Opioid consumption', 'timeFrame': 'On average between 6 and 8 hours postoperatively', 'description': "Subjects' pain will be assessed by tracking opioid consumption postoperatively."}, {'measure': 'Opioid consumption', 'timeFrame': '24 hours (postoperatively)', 'description': "Subjects' pain will be assessed by tracking opioid consumption postoperatively."}, {'measure': 'Motor effects', 'timeFrame': 'On average between 6 and 8 hours postoperatively', 'description': "Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['a continuous proximal adductor canal block (ACB)', 'continuous femoral nerve block (FNB)'], 'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare continuous femoral nerve block with continuous proximal adductor canal block for postoperative pain control and rehabilitation.', 'detailedDescription': 'Patients meeting the criteria: American Society of Anesthesiologists (ASA) class I and II, that are scheduled for elective total knee arthroplasty, will be recruited into the study. Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score of 1 or 2 that are healthy without systemic disease or have mild systemic disease, respectively.\n* The patient will need to be able to have decision-making capacity and ability to consent for the study.\n\nExclusion Criteria:\n\n* Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score greater than 2.\n* Patients unable to have decision-making capacity and ability to consent for the study.'}, 'identificationModule': {'nctId': 'NCT02495805', 'briefTitle': 'Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Ultrasound-guided Continuous Proximal Adductor Canal Versus Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '1508016335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'adductor canal block (ACB)', 'description': 'Subjects randomized to this groups receive a continuous proximal adductor canal block (ACB) during surgery.', 'interventionNames': ['Procedure: Continuous proximal adductor canal block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'femoral nerve block (FNB)', 'description': 'Subjects randomized to this groups receive a continuous femoral nerve block (FNB) during surgery.', 'interventionNames': ['Procedure: Continuous femoral nerve block']}], 'interventions': [{'name': 'Continuous proximal adductor canal block', 'type': 'PROCEDURE', 'otherNames': ['ACB'], 'description': 'Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).', 'armGroupLabels': ['adductor canal block (ACB)']}, {'name': 'Continuous femoral nerve block', 'type': 'PROCEDURE', 'otherNames': ['FNB'], 'description': 'Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).', 'armGroupLabels': ['femoral nerve block (FNB)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Richa Wardham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}