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

NCT02892968 | Unknown

• 1 other identifier: 201503MOP
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Delirium

Keywords

Regional Anesthesia Ultrasound guided; Emergency Department; Knowledge to Practice Intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 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

• Numeric Rating Scale (1-5) Effectiveness of block (pain reduction measured)at 30 minutes

  30 minutes after administration of regional anesthesia

• Supplementary narcotic analgesics used pre-operatively, measured in morphine equivalent units

  Time of Injury to operation measured to a maximum of 7 days

Study Arms (2)

U/S Guided Regional Anesthesia

EXPERIMENTAL

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); Procedure: Femoral Nerve Block(FNB)

Current Local Standard Analgesia

NO 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.

Interventions

Fascia-Iliaca Block(FIB) PROCEDURE

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.

U/S Guided Regional Anesthesia

Femoral Nerve Block(FNB) PROCEDURE

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.

U/S Guided Regional Anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Center

Toronto, Ontario, M4S 3M5, Canada

Location

Related Publications (3)

• Lee JS, Chenkin J, Simard R, Bhandari T, Woo MY, Perry JJ, Eagles D, Wong C, McRae AD, Lang E, Newbigging J, Sivilotti MLA, Chernoff I, Borgundvaag B, McLeod SL, Melady D, Kiss A, Emond M. Ultrasound-Guided Regional Anesthesia by Emergency Physicians for Hip Fractures and Delirium: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2549337. doi: 10.1001/jamanetworkopen.2025.49337.

  PMID: 41396601 DERIVED

• Lee JS, Bhandari T, Simard R, Emond M, Topping C, Woo M, Perry J, Eagles D, McRae AD, Lang E, Wong C, Sivilotti M, Newbigging J, Borgundvaag B, McLeod SL, Melady D, Chernoff L, Kiss A, Chenkin J. Point-of-care ultrasound-guided regional anaesthesia in older ED patients with hip fractures: a study to test the feasibility of a training programme and time needed to complete nerve blocks by ED physicians after training. BMJ Open. 2021 Jul 5;11(7):e047113. doi: 10.1136/bmjopen-2020-047113.

  PMID: 34226222 DERIVED

• Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

  PMID: 33238043 DERIVED

MeSH Terms

Conditions

Hip Fractures; Delirium; Emergencies

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: September 8, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2021
• Last Updated: September 8, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)