Hip FracturesEDU-RAPIDNCT02892968
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
A study testing Fascia-Iliaca Block(FIB) and Femoral Nerve Block(FNB) in people with Hip Fractures and Delirium, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Delirium
- What is being tested?
- Fascia-Iliaca Block(FIB) and Femoral Nerve Block(FNB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Center
Toronto, Ontario, M4S 3M5
Jacques S Lee, MD, 416-480-6100 ext. 7701, jacques.lee@sunnybrook.ca
Jacques S Lee, MD
About this study
Official title: ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients (EDU-RAPID) Multi-center Stepped Wedge Cluster Randomized Trial
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.
Read more
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
- Being tested
- Fascia-Iliaca Block(FIB), Femoral Nerve Block(FNB)
- Keywords
- Regional Anesthesia Ultrasound guided, Emergency Department, Knowledge to Practice Intervention
- Medical subject headings
- Hip Fractures, Delirium, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia-Iliaca Block(FIB)Procedure or surgery
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)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall rate of incident delirium
Measured: Time of injury to post-injury day 7
Time to onset of incident delirium
Measured: Time of injury to post-injury day 7
Secondary outcomes (12)
The rate of regional anesthesia use by intervention physicians for hip fracture patients
Measured: Time of injury to operation to maximum of 7 days
Time to perform the block
Measured: 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
Measured: 30 minutes and 60 minutes after administration of regional anesthesia
Numeric Rating Scale (1-5) Effectiveness of block (pain reduction measured)at 30 minutes
Measured: 30 minutes after administration of regional anesthesia
Supplementary narcotic analgesics used pre-operatively, measured in morphine equivalent units
Measured: Time of Injury to operation measured to a maximum of 7 days
Maximum severity of delirium using the validated Delirium Index (DI)
Measured: Time of injury to post-injury day 7
Cognitive Assessment Method (CAM) status (CAM + or CAM -) measurement at hospital discharge
Measured: Admission to Discharge to a maximum of 100 days
Complications from the regional anesthesia including hematoma and persistent nervous dysfunction
Measured: Time of injury to post-injury day 7
Adverse events, including in-hospital falls, cardiovascular events and deaths; Hospital length of stay
Measured: Time of injury to 1 year follow-up
Functional status measured using Older Americans' Resources and Services (OARS) Activities of Daily Living Questionnaire at 1 month and 1 year follow-up
Measured: 1 month and 1 year follow-up from Time of Injury
Proportion of patients who return to independent living at discharge
Measured: Admission to Discharge to a maximum of 1 year
Mortality within 1 year post-operatively
Measured: 1 year follow-up from time of injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892968
- Sponsor's protocol ID
- 201503MOP
- Acronym
- EDU-RAPID
- Status last verified
- Sep 2016
- First submitted
- 9 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 41396601Lee 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.
PubMed 34226222Guay 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.
PubMed 33238043
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients (EDU-RAPID) Multi-center Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02892968
- Acronym / sponsor ID
- EDU-RAPID / 201503MOP
- Conditions
- Hip Fractures, Delirium
- Keywords
- Regional Anesthesia Ultrasound guided, Emergency Department, Knowledge to Practice Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| U/S Guided Regional Anesthesia | Experimental | Procedure: Fascia-Iliaca Block(FIB), Procedure: 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 |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | U/S Guided Regional Anesthesia |
| 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. | Procedure or surgery | U/S Guided Regional Anesthesia |
Primary outcome
Overall rate of incident delirium
Time frame: Time of injury to post-injury day 7
Time to onset of incident delirium
Time frame: Time of injury to post-injury day 7
12 secondary outcomes
The rate of regional anesthesia use by intervention physicians for hip fracture patients
Time frame: Time of injury to operation to maximum of 7 days
Time to perform the block
Time frame: 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
Time frame: 30 minutes and 60 minutes after administration of regional anesthesia
Numeric Rating Scale (1-5) Effectiveness of block (pain reduction measured)at 30 minutes
Time frame: 30 minutes after administration of regional anesthesia
Supplementary narcotic analgesics used pre-operatively, measured in morphine equivalent units
Time frame: Time of Injury to operation measured to a maximum of 7 days
Maximum severity of delirium using the validated Delirium Index (DI)
Time frame: Time of injury to post-injury day 7
Cognitive Assessment Method (CAM) status (CAM + or CAM -) measurement at hospital discharge
Time frame: Admission to Discharge to a maximum of 100 days
Complications from the regional anesthesia including hematoma and persistent nervous dysfunction
Time frame: Time of injury to post-injury day 7
Adverse events, including in-hospital falls, cardiovascular events and deaths; Hospital length of stay
Time frame: Time of injury to 1 year follow-up
Functional status measured using Older Americans' Resources and Services (OARS) Activities of Daily Living Questionnaire at 1 month and 1 year follow-up
Time frame: 1 month and 1 year follow-up from Time of Injury
Proportion of patients who return to independent living at discharge
Time frame: Admission to Discharge to a maximum of 1 year
Mortality within 1 year post-operatively
Time frame: 1 year follow-up from time of injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Derived from this study: PubMed 41396601Lee 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.
- Derived from this study: PubMed 34226222Lee 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.
- Derived from this study: PubMed 33238043Guay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia-Iliaca Block(FIB) and Femoral Nerve Block(FNB) in people with Hip Fractures and Delirium, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall rate of incident delirium (time frame: Time of injury to post-injury day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02892968, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.