Clinical trial NCT04145752: Nurse Led Ultrasound Guided Femoral Nerve Block in the Emergency Department
Official title: Acute Pain in Hip Fracture Patients: Pain Management in the Emergency Department, a Mixed Method Study¨. Nurse Led Ultrasound Guided Femoral Nerve Block in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Anesthesia
Femoral Neck Fractures
Keywords: femoral nerve block
Ultrasound guided
Nurse-led
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
Collaborators: name: University College of Southeast Norway
First posted: 2019-10-31
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, open label trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to investigate the effects of task shifting from anesthesiologists to special trained nurses performing femoral nerve block (FNB) in patients with hip fracture in the emergency department (ED) at Vestfold Hospital Trust (VHT). A sample of nurses (n= 6) will perform ultrasound guided FNB in hip fracture patients (n=25) admitted to the ED at VHT. This cohort will be compared to another cohort of hip fracture patients (n=25). This cohort will follow standard of care where the femoral nerve block is often performed by anesthesiologists. The study is a prospective, controlled randomized trial.

Detailed description: The ageing population admitted to the ED in developed countries is steadily increasing. Hip fractures are common among the elderly population, and related to increased mortality. Patient satisfaction with ED's has been an international challenge over several years. Acute pain is one of the most common reasons for patients coming admitted to the ED. However, undertreatment of pain is common, particularly in patients with hip fractures.

Pain control can be difficult, and often requires intensive nursing and physician care, as elderly patients may manifest cardiovascular and respiratory complications from opioid administration. Optimizing acute pain management in patients with orthopedic trauma is important and can translate into significant positive physiologic and financial outcomes.

At Vestfold Hospital Trust, pain relief of the hip fracture patient in ED has traditionally most often consisted of paracetamol and opiates. Additionally, the patients are offered FNB by the anesthesiologist, but concurrent conflicts and other organizational circumstances has have led to delayed block or no block for all or some patients. This often necessitate a continuation of pain relief in form of intravenous opioids, with increased risk of opioid side effects such as respiratory depression, delirium, constipation, urinary retention, nausea and vomiting and subsequently increased morbidity and increased costs for the hospital and the community.

The investigators believe that shifting this task to nurses working in the ED can secure patient with hip fractures sufficiently and timely pain relief. By giving trained nurses this new task of performing FNB the investigators can study how expert nurses qualifications' are utilized to strengthen the quality of the ED. This study aims to implement and evaluate the introduction of specially trained nurses performing ultrasound guided FNB in patients with hip fractures in the ED. This implementation may be beneficial to patients in terms of prompt analgesia, reduced opioid consumption, thereby reducing opioid adverse events, and it might influence risk of complications and length of stay. The aim of this study is to evaluate cumulative Numeric Rating Scale (NRS) score during rest and during passive movement (30 degree flexion in the hip) in patients with hip fracture during stay in the ED at 120 minutes after admission, thereby comparing nurse-led FNB versus standard of care.

The study has a randomized controlled trial design. Patients are randomized (1:1) into two groups:

1. Trained nurses in ED provide ultrasound guided single-shot FNB shortly after (at arrival ED) the patient is diagnosed with a hip fracture.
2. Nurses do not provide ultrasound guided single-shot FNB and the patient follows the FAST-TRACK-HIP FRACTURE course local guideline at our hospital.

Hypothesis: A single shot FNB performed by nurses in the ED compared to todays practice will result in lower cumulative NRS score first 120 minutes after admission to ED than current practice.

Eligibility criteria: Inclusion Criteria:

* Patients arriving at the emergency department diagnosed with a hip fracture (X-ray confirmed)
* American Society of Anesthesiologists classification (ASA) 1-4
* Written informed consent by patient

Exclusion Criteria:

* Patients with dementia
* Known allergies to local anesthetic used in femoral nerve block.
* The patient is anticoagulated or uses platelet inhibitors. Acetylsalicylic acid and dipyridamole is allowed. If a recent (last 2 hours) International normalized ratio (INR) is below \<1.5 the patient can be included.
* Pregnant
* Age \<18 years
* Severe head injury which leads to significant loss of consciousness (Glascow coma score (GCS) \<12)
* \>10 mg or more morphine administrated pre-hospital
* Skin lesions/infection at block site
* Patients admitted with other suspected or verified fractures, except small fractures in hands and foots.

Primary outcomes:
measure: Cumulative dynamic pain score - Numerical Rating Scale (NRS) - during passive movement at 120 minutes after start of procedure
timeFrame: 120 minutes
Secondary outcomes:
measure: Number of total morphine equivalents - 24h
timeFrame: 24 hours
measure: Number of total morphine equivalents - Hospital stay
timeFrame: approx. 6 days
measure: Cumulative rest pain score -Numerical Rating Scale (NRS) - at 120 minutes after start of procedure
timeFrame: 120 minutes
Other outcomes:
measure: Incidence of delirium during hospital stay.
timeFrame: Approx. 6 days
measure: RASS-score - Richmond Agitation and Sedation Scale
timeFrame: Daily - approx. 6 days
measure: Number of (mg) administered of antiemetics during hospital stay
timeFrame: approx. 6 days
measure: Time (minutes) to perform an ultrasound guided femoral nerve block performed
timeFrame: approx 30 minutes
measure: Time from arrival at the emergency department to femoral nerve block is performed
timeFrame: Approx 1 hour
measure: Time from admission to surgery starts
timeFrame: approx. 48 hours
measure: Length of total hospital stay
timeFrame: Approx. 6 days
measure: Mortality during hospitalization
timeFrame: Approx. 6 days
measure: Mortality 30 days
timeFrame: 30 days
measure: Hospital acquired pneumonia
timeFrame: Approx 6 days
measure: Acute myocardial infarction
timeFrame: Approx 6 days
measure: Acute renal failure
timeFrame: Approx 6 days
measure: Respiratory failure
timeFrame: Approx 6 days
measure: Intravasal injection
timeFrame: 24 hours
measure: Hematoma
timeFrame: 24 hours
measure: Neurologic systemic outcomes / symptoms / paresthesia
timeFrame: Approx 6 days
Locations:
city: Tonsberg
country: Norway
facility: Sykehuset i Vestfold HF
Study officials:
affiliation: The Hospital of Vestfold
name: Elin Saga, nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.