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Completed

NCT Number: NCT04145752

Nurse Led Ultrasound Guided Femoral Nerve Block in the Emergency Department

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.

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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sykehuset i Vestfold HF

Tønsberg, 3103, Norway

About this study

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:

  • Trained nurses in ED provide ultrasound guided single-shot FNB shortly after (at arrival ED) the patient is diagnosed with a hip fracture.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nurse-led femoral nerve block

Procedure

The nurse perform a femoral nerve block in the emergency department in patients diagnosed with a hip fracture (x-ray)

Primary outcomes

  1. Cumulative dynamic pain score - Numerical Rating Scale (NRS) - during passive movement at 120 minutes after start of procedure

    Time frame: 120 minutes

    Cumulative dynamic pain score - Numerical Rating Scale (NRS) - during passive movement (30 degree flexion in the fractured hip) in patients with hip fracture during stay in the ED at 120 minutes after admission, measured by five time Points; At the end of procedure, 30 min.-, 60 min.-, 90 min.- and 120 min after start of procedure. NRS score: 0 is no pain and 10 is the worst pain.

Secondary outcomes

  1. Number of total morphine equivalents - 24h

    Time frame: 24 hours

    Number of total morphine equivalents, mg (iv/po) administered during first 24 hours from admission at the emergency department

  2. Number of total morphine equivalents - Hospital stay

    Time frame: approx. 6 days

    Number of total morphine equivalents, mg (iv/po) administered during total hospital stay.

  3. Cumulative rest pain score -Numerical Rating Scale (NRS) - at 120 minutes after start of procedure

    Time frame: 120 minutes

    Cumulative rest pain score NRS - Numerical Rating Scale (NRS) - in patients with hip fracture during stay in the emergency department at 120 minutes after admission, measured by five time Points; At the end of procedure, 30 min.-, 60 min.-, 90 min.- and 120 min after start of procedure. NRS score: 0 is no pain and 10 is the worst pain.

Other outcomes

  1. Incidence of delirium during hospital stay.

    Time frame: Approx. 6 days

    Incidence of delirium, measured by Assessment test for delirium & cognitive impairment - 4AT, will be performed daily during hospital stay, number of patients

  2. RASS-score - Richmond Agitation and Sedation Scale

    Time frame: Daily - approx. 6 days

    Measure consciousness assessed by RASS-score - Richmond Agitation and Sedation Scale - (at admittance to the emergency department and daily). Total score. RAAS is a10-point scale, with four levels of anxiety or agitation (+1 to +4), one level to denote a calm and alert state (0), and 5 levels of sedation (-1 to -5) culminating in unarousable (-5).

  3. Number of (mg) administered of antiemetics during hospital stay

    Time frame: approx. 6 days

    Number of (mg) administered of antiemetics ( ondansetron, dexagalen, metoclopramide) during first 24 hours and during hospital stay.

  4. Time (minutes) to perform an ultrasound guided femoral nerve block performed

    Time frame: approx 30 minutes

    Time (minutes) used to perform an ultrasound guided femoral nerve block performed by nurses.

  5. Time from arrival at the emergency department to femoral nerve block is performed

    Time frame: Approx 1 hour

    Time (min.) from arrival at emergency department (from Radiological Department) to femoral nerve block is performed.

  6. Time from admission to surgery starts

    Time frame: approx. 48 hours

    Time from admission to surgery starts, minutes

  7. Length of total hospital stay

    Time frame: Approx. 6 days

    Length of total hospital stay, days

  8. Mortality during hospitalization

    Time frame: Approx. 6 days

    Mortality during hospitalization, Yes or no

  9. Mortality 30 days

    Time frame: 30 days

    Mortality at postoperative day 30, Yes or no

  10. Hospital acquired pneumonia

    Time frame: Approx 6 days

    Hospital acquired pneumonia during hospital stay, Yes or no

  11. Acute myocardial infarction

    Time frame: Approx 6 days

    Acute myocardial infarction during hospital stay, Yes or no

  12. Acute renal failure

    Time frame: Approx 6 days

    Acute renal failure during hospital stay, Yes or no

  13. Respiratory failure

    Time frame: Approx 6 days

    Respiratory failure during hospital stay, Yes or no

  14. Intravasal injection

    Time frame: 24 hours

    Intravasal injection - visually + circulatory and neurological symptoms, Yes or no

  15. Hematoma

    Time frame: 24 hours

    Hematoma - defined as a new tumor > 2 centimeter in the groin / injection site measured by ultrasound, Yes or no

  16. Neurologic systemic outcomes / symptoms / paresthesia

    Time frame: Approx 6 days

    Neurologic systemic outcomes / symptoms / paresthesia that have occurred after admission and which persist until discharge, numbers

Sponsors and collaborators

Lead sponsor

Espen Lindholm

Other

Collaborators

  • University College of Southeast Norway

Registry information

Official study 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

Acronym: URGENT

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 31, 2019
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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