Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-04-16 @ 12:16 AM
Study NCT ID:
NCT02742961
Status:
COMPLETED
Last Update Posted:
2016-04-19
First Post:
2016-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Peripheral Nerve Blockade on Outcomes After Total Knee Replacement
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178214}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2016-04-13', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'Day of surgery to 30 days after surgery', 'description': "Identified from the Registered Person's Database that records the date of death for all residents of Ontario"}], 'primaryOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': 'Day of surgery to day of discharge, or up to 365 days, whichever comes first', 'description': 'Determined from the Canadian Institute for Health Information Discharge Abstract Database record for the index hospitalization'}], 'secondaryOutcomes': [{'measure': 'Hospital readmission', 'timeFrame': 'The outcome ascertainment window starts on the day of discharge and extends up to 30 days after surgery. Any readmission in this time period will be considered an event.', 'description': 'Determined from the Canadian Institute for Health Information Discharge Abstract Database through identification of a new record after discharge from the index hospitalization'}, {'measure': 'In-hospital fall', 'timeFrame': 'hospital admission', 'description': 'Determined using validated International Classification of Diseases Tenth edition codes for falls from the index hospitalization Discharge Abstract Database record'}, {'measure': 'Emergency department visit', 'timeFrame': 'The outcome ascertainment window starts on the day of discharge and extends up to 30 days after surgery. Any emergency department visit in this time period will be considered an event.', 'description': 'Defined as the creation of a record in the National Ambulatory Care Reporting System for an emergency department visit that occurs after discharge and before 30 days after discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['orthopedics', 'anesthesiology', 'nerve block', 'length of stay', 'Patient readmission'], 'conditions': ['Pain', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Pain is common after knee replacement surgery and can impact a variety of patient outcomes. Peripheral nerve blocks provide improved pain control and may improve function. However, their impact on other outcomes is poorly described. Therefore, this comparative effectiveness study will estimate the independent association between nerve blocks and health outcomes after knee replacement surgery.', 'detailedDescription': 'This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient and health system outcomes after elective total knee replacement surgery.\n\nThe investigators will develop a non-parsimonious propensity score to control for potential indication bias and confounding in this observational study. Using the propensity score the investigators will match patients who receive a peripheral nerve block to a patient who did not to estimate the independent association of peripheral nerve blocks with our study outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adults having their first total knee replacement during the study period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first primary total knee replacement during the study period\n\nExclusion Criteria:\n\n* Revision arthroplasty'}, 'identificationModule': {'nctId': 'NCT02742961', 'briefTitle': 'Impact of Peripheral Nerve Blockade on Outcomes After Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Impact of Peripheral Nerve Blockade on Outcomes After Total Knee Replacement', 'orgStudyIdInfo': {'id': 'DM1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peripheral nerve block', 'description': 'Intervention arm. Participants who receive a peripheral nerve block identified through submission of an appropriate physician billing code', 'interventionNames': ['Other: Peripheral nerve block']}, {'label': 'No peripheral nerve block', 'description': 'Control arm. Participants who do not receive a peripheral nerve block identified through lack of a submission of an appropriate physician billing code'}], 'interventions': [{'name': 'Peripheral nerve block', 'type': 'OTHER', 'description': 'A physician billing code for deposition of a local anesthetic solution around an anatomically defined nerve or nerve plexus', 'armGroupLabels': ['Peripheral nerve block']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Scientist', 'investigatorFullName': 'Dan McIsaac', 'investigatorAffiliation': 'Ottawa Hospital Research Institute'}}}}