Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-30 @ 4:31 AM
Study NCT ID:
NCT01459861
Status:
TERMINATED
Last Update Posted:
2013-03-06
First Post:
2011-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Ambulation After Adductor Canal Block for Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Administratively closed early', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-04', 'studyFirstSubmitDate': '2011-10-06', 'studyFirstSubmitQcDate': '2011-10-24', 'lastUpdatePostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to ambulate post operatively.', 'timeFrame': 'Up to 3 days (72 hours) post surgery.', 'description': 'Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.'}], 'secondaryOutcomes': [{'measure': 'Pain scores at rest and with knee flexion.', 'timeFrame': 'Up to 3 days ( 72 hours) after surgery', 'description': 'Measures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 72 hour period after discharge from recovery room.'}, {'measure': 'Pain Medication Consumption', 'timeFrame': 'Up to 3 days (72 hours) post surgery', 'description': 'Amount of opioid consumption post surgery for 72 hours.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['early ambulation', 'knee arthroplasty'], 'conditions': ['Pain', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess early ambulation following total knee replacement in patients receiving continuous adductor canal block with posterior capsular injection compared to continuous femoral nerve block with tibial nerve block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* knee arthroplasty\n* ages 18-80\n\nExclusion Criteria:\n\n* history of neurological disease\n* diabetes\n* pregnancy\n* neuropathy\n* chronic narcotic use\n* allergy to local anesthetic solution or NSAIDS\n* inability to give consent or cooperate with the study protocol'}, 'identificationModule': {'nctId': 'NCT01459861', 'briefTitle': 'Early Ambulation After Adductor Canal Block for Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Trinity Health Of New England'}, 'officialTitle': 'Assessment of Early Ambulation in Patients Receiving Continuous Adductor Canal Block With Ultrasound Guided Posterior Capsular Knee Injection vs. Femoral Nerve Block With Tibial Nerve Block Following Total Knee Replacement', 'orgStudyIdInfo': {'id': '11-09-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canal Block and Capsular Injection', 'description': 'Adductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution.', 'interventionNames': ['Procedure: Canal Block and Capsular Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral with Tibial Nerve Block', 'description': 'Continuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa.', 'interventionNames': ['Procedure: Femoral Nerve Block with Tibial Nerve Block']}], 'interventions': [{'name': 'Canal Block and Capsular Injection', 'type': 'PROCEDURE', 'description': 'Continuous Adductor canal block with 15ml of ropivacaine 0.2% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30ml ropivacaine 0.2% with epinephrine 1:400,000.', 'armGroupLabels': ['Canal Block and Capsular Injection']}, {'name': 'Femoral Nerve Block with Tibial Nerve Block', 'type': 'PROCEDURE', 'description': 'Continuous femoral nerve block with 15ml of ropivacaine 0.2% followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.5% up to 15ml.', 'armGroupLabels': ['Femoral with Tibial 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, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Francis Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trinity Health Of New England', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}