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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02892968
Acronym
EDU-RAPID
Enrollment
800
Registered
2016-09-08
Start date
2016-09-30
Completion date
2021-12-31
Last updated
2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Hip Fractures

Keywords

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

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.

Interventions

PROCEDUREFascia-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.

PROCEDUREFemoral 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.

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Overall rate of incident deliriumTime of injury to post-injury day 7
Time to onset of incident deliriumTime of injury to post-injury day 7

Secondary

MeasureTime frame
Pain Severity on 0-10 Numeric Rating Scale as assessed by treating MD or Nurse after administration of regional anesthesia30 minutes and 60 minutes after administration of regional anesthesia
Numeric Rating Scale (1-5) Effectiveness of block (pain reduction measured)at 30 minutes30 minutes after administration of regional anesthesia
Supplementary narcotic analgesics used pre-operatively, measured in morphine equivalent unitsTime of Injury to operation measured to a maximum of 7 days
Maximum severity of delirium using the validated Delirium Index (DI)Time of injury to post-injury day 7
Cognitive Assessment Method (CAM) status (CAM + or CAM -) measurement at hospital dischargeAdmission to Discharge to a maximum of 100 days
The rate of regional anesthesia use by intervention physicians for hip fracture patientsTime of injury to operation to maximum of 7 days
Adverse events, including in-hospital falls, cardiovascular events and deaths; Hospital length of stayTime 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-up1 month and 1 year follow-up from Time of Injury
Proportion of patients who return to independent living at dischargeAdmission to Discharge to a maximum of 1 year
Mortality within 1 year post-operatively1 year follow-up from time of injury
Complications from the regional anesthesia including hematoma and persistent nervous dysfunctionTime of injury to post-injury day 7
Time to perform the blockTime block started to completion to maximum of 2 hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026