Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-03-01 @ 10:04 AM
Study NCT ID:
NCT02228759
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2014-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2014-08-18', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'first 24 hour pain scores', 'timeFrame': '24 hours'}, {'measure': 'first 96 hour pain scores', 'timeFrame': '96 hours'}, {'measure': 'Rescue analgesic frequency', 'timeFrame': '24 hours'}, {'measure': 'total analgesic usage in the first 24 and 96 postoperative hours', 'timeFrame': '96 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ambulatory home regional', 'adductor canal block', 'Postoperative pain', 'total knee arthroplasty', 'Home regional', 'Fast track arthroplasty'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '18362603', 'type': 'BACKGROUND', 'citation': 'Ilfeld BM, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.'}]}, 'descriptionModule': {'briefSummary': 'Patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks with continuous adductor canal block along with multimodal analgesia started pre-operatively and continued into the postoperative period. The study will evaluate the feasibility of home discharge within the first 24 hours following total knee arthroplasty. We will also evaluate the pain scores in the first 5 days following the surgery, causes of delayed discharge and any adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and females of 40-70years of age\n2. Scheduled to undergo unilateral primary total knee arthroplasty\n3. ASA Class I, II\n\nExclusion Criteria:\n\n1. ASA 3, 4\n2. Revision surgery\n3. Narcotic dependent (opioid intake morphine equivalent \\> 10 mg/ day for more than 3 months)\n4. Other sources of chronic pain like fibromyalgia\n5. Patients with associated significant cardiac, CNS or respiratory disease (poor cardio-respiratory reserve)\n6. Major conduction defects in EKG (bifascilular block, CHB); significant valvular heart disease\n7. Recent MI/ Stroke/ CHF (in the past 3 months)\n8. BMI\\> 35\n9. Obstructive sleep apnea (AHI \\> 15)\n10. Patients with coexisting hematological disorder or with deranged coagulation parameters.\n11. Patients with pre-existing major organ dysfunction such as hepatic and renal failure.\n12. Psychiatric illnesses\n13. Uncontrolled diabetes mellitus\n14. Lack of informed consent.\n15. Allergy to any of the drugs used in the study\n16. Preoperative neurological deficits\n17. Use of walking aids preoperatively\n18. Living alone (Lack of Chaperone/home help)\n19. Language barrier\n20. Contralateral leg weakness\n21. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02228759', 'briefTitle': 'Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'orgStudyIdInfo': {'id': '105097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adductor canal block', 'description': 'The study is an open label pilot study to determine the feasibility of same day discharge following total knee arthroplasty with the use of a fast track regimen employing motor sparing knee blocks. The study will be performed on 25 American Society of Anesthesiologists class (ASA) 1-2 patients satisfying the inclusion criteria and undergoing unilateral primary total knee arthroplasty. First and second patients of the day undergoing surgery between Monday to Thursday in a week will be accessed for the study.', 'interventionNames': ['Procedure: Adductor canal block']}], 'interventions': [{'name': 'Adductor canal block', 'type': 'PROCEDURE', 'description': 'All patients will recieve fast tracking with reduced fasting times, multimodal analgesia and adductor canal block', 'armGroupLabels': ['Adductor canal block']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University hospital, London Health Sciences centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sugantha Ganapathy', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}