ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients

Not Applicable

• Conditions: Hip Fractures; Delirium
• Interventions: Procedure: Fascia-Iliaca Block(FIB); Procedure: Femoral Nerve Block(FNB)

• Registration Number: NCT02892968
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-08-09
• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-01
• Last Update Submitted: 2016-09-01
• Study First Posted: 2016-09-08
• Last Update Posted: 2016-09-08
• Primary Completion: 2020-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
U/S Guided Regional Anesthesia	Fascia-Iliaca Block(FIB)	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
U/S Guided Regional Anesthesia	Femoral Nerve Block(FNB)	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

Primary Outcome Measures

Name	Time	Method
Overall rate of incident delirium	Time of injury to post-injury day 7
Time to onset of incident delirium	Time of injury to post-injury day 7

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Center; 🇨🇦 Toronto, Ontario, Canada