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Trial record 1 of 1 for:    Jacques Lee | Recruiting, Not yet recruiting Studies | hip fracture | Canada
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ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients (EDU-RAPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02892968
Recruitment Status : Not yet recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Brief Summary:

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.

Using 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.

The 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.

If 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.


Condition or disease Intervention/treatment Phase
Hip Fractures Delirium Procedure: Fascia-Iliaca Block(FIB) Procedure: Femoral Nerve Block(FNB) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients (EDU-RAPID) Multi-center Stepped Wedge Cluster Randomized Trial
Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: U/S Guided Regional Anesthesia

Fascia-Iliaca Block(FIB) Femoral Nerve Block(FNB)

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". 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

Procedure: Fascia-Iliaca Block(FIB)
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.

Procedure: Femoral Nerve Block(FNB)
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.

No Intervention: Current Local Standard Analgesia
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.



Primary Outcome Measures :
  1. Overall rate of incident delirium [ Time Frame: Time of injury to post-injury day 7 ]
  2. Time to onset of incident delirium [ Time Frame: Time of injury to post-injury day 7 ]

Secondary Outcome Measures :
  1. The rate of regional anesthesia use by intervention physicians for hip fracture patients [ Time Frame: Time of injury to operation to maximum of 7 days ]
  2. Time to perform the block [ Time Frame: Time block started to completion to maximum of 2 hours ]
  3. Pain Severity on 0-10 Numeric Rating Scale as assessed by treating MD or Nurse after administration of regional anesthesia [ Time Frame: 30 minutes and 60 minutes after administration of regional anesthesia ]
  4. Numeric Rating Scale (1-5) Effectiveness of block (pain reduction measured)at 30 minutes [ Time Frame: 30 minutes after administration of regional anesthesia ]
  5. Supplementary narcotic analgesics used pre-operatively, measured in morphine equivalent units [ Time Frame: Time of Injury to operation measured to a maximum of 7 days ]
  6. Maximum severity of delirium using the validated Delirium Index (DI) [ Time Frame: Time of injury to post-injury day 7 ]
  7. Cognitive Assessment Method (CAM) status (CAM + or CAM -) measurement at hospital discharge [ Time Frame: Admission to Discharge to a maximum of 100 days ]
  8. Complications from the regional anesthesia including hematoma and persistent nervous dysfunction [ Time Frame: Time of injury to post-injury day 7 ]
  9. Adverse events, including in-hospital falls, cardiovascular events and deaths; Hospital length of stay [ Time Frame: Time of injury to 1 year follow-up ]
  10. Functional status measured using Older Americans' Resources and Services (OARS) Activities of Daily Living Questionnaire at 1 month and 1 year follow-up [ Time Frame: 1 month and 1 year follow-up from Time of Injury ]
  11. Proportion of patients who return to independent living at discharge [ Time Frame: Admission to Discharge to a maximum of 1 year ]
  12. Mortality within 1 year post-operatively [ Time Frame: 1 year follow-up from time of injury ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At the cluster level, ED physicians practicing at a participating site will be eligible.
  • At the patient level, all hip fractures seen by a participating ED physician will be eligible

Exclusion Criteria:

  • ED physicians who work casually (less than 0.25 Full Time Equivalent)
  • ED Physicians who are routinely using U/S guided RA for hip fracture patients, or decline participation in the trial.
  • Patients' age less than 65 years;
  • Patients who are delirious on initial assessment by ED physician or severe dementia
  • Patients with communication problems (critically ill, unconscious, language barrier despite use of secure telephone-based translation service)
  • Patients with allergies to narcotics or local anesthetic; or anticoagulant use (e.g. warfarin, dabigatran, rivaroxaban).
  • Patients with hip fractures not requiring surgery (e.g. greater trochanter avulsion) will also be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892968


Locations
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Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4S 3M5
Contact: Jacques S Lee, MD    416-480-6100 ext 7701    jacques.lee@sunnybrook.ca   
Principal Investigator: Jacques S Lee, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02892968    
Other Study ID Numbers: 201503MOP
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sunnybrook Health Sciences Centre:
Regional Anesthesia Ultrasound guided
Emergency Department
Knowledge to Practice Intervention
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Femoral Fractures
Hip Injuries
Delirium
Wounds and Injuries
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Leg Injuries