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

Delirium Clinical Trial

— EDU-RAPID  

Official title:

ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients (EDU-RAPID) Multi-center Stepped Wedge Cluster Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02892968
• Other study ID #: 201503MOP
• Status: Not yet recruiting
• Phase: N/A
• First received: August 9, 2016
• Last updated: September 1, 2016
• Start date: September 2016
• Est. completion date: December 2021

Study information

• Verified date: September 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium
• Fractures, Bone
• Hip Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall rate of incident delirium		Time of injury to post-injury day 7	No
Primary	Time to onset of incident delirium		Time of injury to post-injury day 7	No
Secondary	The rate of regional anesthesia use by intervention physicians for hip fracture patients		Time of injury to operation to maximum of 7 days	No
Secondary	Time to perform the block		Time block started to completion to maximum of 2 hours	No
Secondary	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	No
Secondary	Numeric Rating Scale (1-5) Effectiveness of block (pain reduction measured)at 30 minutes		30 minutes after administration of regional anesthesia	No
Secondary	Supplementary narcotic analgesics used pre-operatively, measured in morphine equivalent units		Time of Injury to operation measured to a maximum of 7 days	No
Secondary	Maximum severity of delirium using the validated Delirium Index (DI)		Time of injury to post-injury day 7	No
Secondary	Cognitive Assessment Method (CAM) status (CAM + or CAM -) measurement at hospital discharge		Admission to Discharge to a maximum of 100 days	No
Secondary	Complications from the regional anesthesia including hematoma and persistent nervous dysfunction		Time of injury to post-injury day 7	No
Secondary	Adverse events, including in-hospital falls, cardiovascular events and deaths; Hospital length of stay		Time of injury to 1 year follow-up	No
Secondary	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	No
Secondary	Proportion of patients who return to independent living at discharge		Admission to Discharge to a maximum of 1 year	No
Secondary	Mortality within 1 year post-operatively		1 year follow-up from time of injury	No