ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients (EDU-RAPID)

Sunnybrook Health Sciences Centre

Status: Unknown

Conditions: Hip Fractures; Delirium

Treatments: Procedure: Fascia-Iliaca Block(FIB); Procedure: Femoral Nerve Block(FNB)

Study type: Interventional

Funder types: Other

Identifiers

NCT02892968

201503MOP

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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800 participants in 2 patient groups

U/S Guided Regional Anesthesia

Experimental group

Description:

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

Treatment:

Procedure: Femoral Nerve Block(FNB)

Procedure: Fascia-Iliaca Block(FIB)

Current Local Standard Analgesia

No Intervention group

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.