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U/S Guided Regional Anesthesia for Delirium (EDU-RAPID Trial)

N/A
Waitlist Available
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Delirium
  • Trochanteric Fractures
  • Hip Fracture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: U/S Guided Regional AnesthesiaExperimental Treatment2 Interventions
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
Group II: Current Local Standard AnalgesiaActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,091 Total Patients Enrolled
5 Trials studying Delirium
4,194 Patients Enrolled for Delirium
~87 spots leftby Nov 2025