Nurse Led Ultrasound Guided Femoral Nerve Block in the Emergency Department

Anesthesia Clinical Trial

— URGENT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145752
• Other study ID #: URGENT 2019
• Status: Completed
• Phase: N/A
• Start date: February 11, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2023
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Emergencies
• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures

Intervention

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

Locations

Country	Name	City	State
Norway	Sykehuset i Vestfold HF	Tonsberg

Sponsors (2)

Lead Sponsor	Collaborator
Espen Lindholm	University College of Southeast Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of delirium during hospital stay.	Incidence of delirium, measured by Assessment test for delirium & cognitive impairment - 4AT, will be performed daily during hospital stay, number of patients	Approx. 6 days
Other	RASS-score - Richmond Agitation and Sedation Scale	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).	Daily - approx. 6 days
Other	Number of (mg) administered of antiemetics during hospital stay	Number of (mg) administered of antiemetics ( ondansetron, dexagalen, metoclopramide) during first 24 hours and during hospital stay.	approx. 6 days
Other	Time (minutes) to perform an ultrasound guided femoral nerve block performed	Time (minutes) used to perform an ultrasound guided femoral nerve block performed by nurses.	approx 30 minutes
Other	Time from arrival at the emergency department to femoral nerve block is performed	Time (min.) from arrival at emergency department (from Radiological Department) to femoral nerve block is performed.	Approx 1 hour
Other	Time from admission to surgery starts	Time from admission to surgery starts, minutes	approx. 48 hours
Other	Length of total hospital stay	Length of total hospital stay, days	Approx. 6 days
Other	Mortality during hospitalization	Mortality during hospitalization, Yes or no	Approx. 6 days
Other	Mortality 30 days	Mortality at postoperative day 30, Yes or no	30 days
Other	Hospital acquired pneumonia	Hospital acquired pneumonia during hospital stay, Yes or no	Approx 6 days
Other	Acute myocardial infarction	Acute myocardial infarction during hospital stay, Yes or no	Approx 6 days
Other	Acute renal failure	Acute renal failure during hospital stay, Yes or no	Approx 6 days
Other	Respiratory failure	Respiratory failure during hospital stay, Yes or no	Approx 6 days
Other	Intravasal injection	Intravasal injection - visually + circulatory and neurological symptoms, Yes or no	24 hours
Other	Hematoma	Hematoma - defined as a new tumor > 2 centimeter in the groin / injection site measured by ultrasound, Yes or no	24 hours
Other	Neurologic systemic outcomes / symptoms / paresthesia	Neurologic systemic outcomes / symptoms / paresthesia that have occurred after admission and which persist until discharge, numbers	Approx 6 days
Primary	Cumulative dynamic pain score - Numerical Rating Scale (NRS) - during passive movement at 120 minutes after start of procedure	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.	120 minutes
Secondary	Number of total morphine equivalents - 24h	Number of total morphine equivalents, mg (iv/po) administered during first 24 hours from admission at the emergency department	24 hours
Secondary	Number of total morphine equivalents - Hospital stay	Number of total morphine equivalents, mg (iv/po) administered during total hospital stay.	approx. 6 days
Secondary	Cumulative rest pain score -Numerical Rating Scale (NRS) - at 120 minutes after start of procedure	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.	120 minutes