Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT02892968
Status:
UNKNOWN
Last Update Posted:
2016-09-08
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-01', 'studyFirstSubmitDate': '2016-08-09', 'studyFirstSubmitQcDate': '2016-09-01', 'lastUpdatePostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall rate of incident delirium', 'timeFrame': 'Time of injury to post-injury day 7'}, {'measure': 'Time to onset of incident delirium', 'timeFrame': 'Time of injury to post-injury day 7'}], 'secondaryOutcomes': [{'measure': 'The rate of regional anesthesia use by intervention physicians for hip fracture patients', 'timeFrame': 'Time of injury to operation to maximum of 7 days'}, {'measure': 'Time to perform the block', 'timeFrame': 'Time block started to completion to maximum of 2 hours'}, {'measure': 'Pain Severity on 0-10 Numeric Rating Scale as assessed by treating MD or Nurse after administration of regional anesthesia', 'timeFrame': '30 minutes and 60 minutes after administration of regional anesthesia'}, {'measure': 'Numeric Rating Scale (1-5) Effectiveness of block (pain reduction measured)at 30 minutes', 'timeFrame': '30 minutes after administration of regional anesthesia'}, {'measure': 'Supplementary narcotic analgesics used pre-operatively, measured in morphine equivalent units', 'timeFrame': 'Time of Injury to operation measured to a maximum of 7 days'}, {'measure': 'Maximum severity of delirium using the validated Delirium Index (DI)', 'timeFrame': 'Time of injury to post-injury day 7'}, {'measure': 'Cognitive Assessment Method (CAM) status (CAM + or CAM -) measurement at hospital discharge', 'timeFrame': 'Admission to Discharge to a maximum of 100 days'}, {'measure': 'Complications from the regional anesthesia including hematoma and persistent nervous dysfunction', 'timeFrame': 'Time of injury to post-injury day 7'}, {'measure': 'Adverse events, including in-hospital falls, cardiovascular events and deaths; Hospital length of stay', 'timeFrame': 'Time of injury to 1 year follow-up'}, {'measure': "Functional status measured using Older Americans' Resources and Services (OARS) Activities of Daily Living Questionnaire at 1 month and 1 year follow-up", 'timeFrame': '1 month and 1 year follow-up from Time of Injury'}, {'measure': 'Proportion of patients who return to independent living at discharge', 'timeFrame': 'Admission to Discharge to a maximum of 1 year'}, {'measure': 'Mortality within 1 year post-operatively', 'timeFrame': '1 year follow-up from time of injury'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Regional Anesthesia Ultrasound guided', 'Emergency Department', 'Knowledge to Practice Intervention'], 'conditions': ['Hip Fractures', 'Delirium']}, 'referencesModule': {'references': [{'pmid': '41396601', 'type': 'DERIVED', 'citation': 'Lee JS, Chenkin J, Simard R, Bhandari T, Woo MY, Perry JJ, Eagles D, Wong C, McRae AD, Lang E, Newbigging J, Sivilotti MLA, Chernoff I, Borgundvaag B, McLeod SL, Melady D, Kiss A, Emond M. Ultrasound-Guided Regional Anesthesia by Emergency Physicians for Hip Fractures and Delirium: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2549337. doi: 10.1001/jamanetworkopen.2025.49337.'}, {'pmid': '34226222', 'type': 'DERIVED', 'citation': 'Lee JS, Bhandari T, Simard R, Emond M, Topping C, Woo M, Perry J, Eagles D, McRae AD, Lang E, Wong C, Sivilotti M, Newbigging J, Borgundvaag B, McLeod SL, Melady D, Chernoff L, Kiss A, Chenkin J. Point-of-care ultrasound-guided regional anaesthesia in older ED patients with hip fractures: a study to test the feasibility of a training programme and time needed to complete nerve blocks by ED physicians after training. BMJ Open. 2021 Jul 5;11(7):e047113. doi: 10.1136/bmjopen-2020-047113.'}, {'pmid': '33238043', 'type': 'DERIVED', 'citation': 'Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.'}]}, 'descriptionModule': {'briefSummary': "Hip fractures are common, costly and affect older people - Canadians spend 1 billion dollars to treat hip fractures each year. Unfortunately, as many as two-thirds of hip fracture cases suffer a complication known as delirium, or acute confusion. Patients with delirium may become frightened and agitated. This in turn leads to other serious problems. Having delirium doubles the chances of dying or can increase the need for admission into a nursing home. People with delirium spend an extra week in hospital on average.\n\nUsing ultrasound to locate and 'freeze' or block specific nerves can stop hip fracture pain almost immediately, and use of this technique is known to reduce delirium when administered by Anaesthetists to patients at the time of their hip operation. Unfortunately, patients with hip fractures commonly wait hours or even days in the Emergency Department (ED) prior to their operation. Currently, these patients are given narcotic pain killers like morphine to dull their pain, as most ED physicians have not been trained in using this 'freezing' technique and Anaesthetists are rarely able to leave the operating room to administer freezing to patient in the ED.\n\nThe EDU-RAPID study will test whether training ED physicians on how to use the nerve freezing technique will reduce the number of patients who develop delirium after a hip fracture. To study this, ED physicians will be trained at 6 hospitals in small groups every 6 weeks over 18 months. The study will look at how patients who are treated by ED physician who has been trained compare to patients treated by a ED physician who has not yet been trained. Also, the study will see if the training motivates ED physicians to use the block regularly.\n\nIf correct, this study could significantly improve the comfort, quality of life, and independence of patients who suffer a hip fracture. In addition, if the study shows a reduction in delirium rates, this could represent a significant cost reduction to the health care system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At the cluster level, ED physicians practicing at a participating site will be eligible.\n* At the patient level, all hip fractures seen by a participating ED physician will be eligible\n\nExclusion Criteria:\n\n* ED physicians who work casually (less than 0.25 Full Time Equivalent)\n* ED Physicians who are routinely using U/S guided RA for hip fracture patients, or decline participation in the trial.\n* Patients' age less than 65 years;\n* Patients who are delirious on initial assessment by ED physician or severe dementia\n* Patients with communication problems (critically ill, unconscious, language barrier despite use of secure telephone-based translation service)\n* Patients with allergies to narcotics or local anesthetic; or anticoagulant use (e.g. warfarin, dabigatran, rivaroxaban).\n* Patients with hip fractures not requiring surgery (e.g. greater trochanter avulsion) will also be excluded."}, 'identificationModule': {'nctId': 'NCT02892968', 'acronym': 'EDU-RAPID', 'briefTitle': 'ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients (EDU-RAPID) Multi-center Stepped Wedge Cluster Randomized Trial', 'orgStudyIdInfo': {'id': '201503MOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'U/S Guided Regional Anesthesia', 'description': 'Fascia-Iliaca Block(FIB) Femoral Nerve Block(FNB)\n\nAll participating emergency physicians (EPs) will be randomly assigned to the order they receive training in a stepped wedge design. Thus all EPs will begin the trial as "control physicians". EPs will then be trained to use two approaches to ultrasound (U/S) guided regional anesthesia, the fascia iliaca and femoral nerve blocks. Which block that will be used will be randomly determined at the individual patient level', 'interventionNames': ['Procedure: Fascia-Iliaca Block(FIB)', 'Procedure: Femoral Nerve Block(FNB)']}, {'type': 'NO_INTERVENTION', 'label': 'Current Local Standard Analgesia', 'description': 'All participating emergency physicians (EPs) will be randomly assigned to the order they receive training in a stepped wedge design. Thus all EPs will begin the trial as "control physicians". Physicians who are in the control group will provide current local standard of analgesic care for hip fracture patients such as the use of IV opiods with supplemental acetaminophen and non-steroidal anti-inflammatory agents until they receive training.'}], 'interventions': [{'name': 'Fascia-Iliaca Block(FIB)', 'type': 'PROCEDURE', 'description': 'The target of the FIB is the potential space between the fascia iliaca and the iliacus muscle, at least 4 cm lateral to the Femoral artery. This is neither a drug nor a device.', 'armGroupLabels': ['U/S Guided Regional Anesthesia']}, {'name': 'Femoral Nerve Block(FNB)', 'type': 'PROCEDURE', 'description': 'The target of the FNB technique is the intersection of the fascia iliaca and the femoral nerve. This is neither a drug nor a device.', 'armGroupLabels': ['U/S Guided Regional Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4S 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Jacques S Lee, MD', 'role': 'CONTACT', 'email': 'jacques.lee@sunnybrook.ca', 'phone': '416-480-6100', 'phoneExt': '7701'}, {'name': 'Jacques S Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}