Nurse Led Ultrasound Guided Femoral Nerve Block in the Emergency Department (URGENT)

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Femoral Neck Fractures; Anesthesia
• Intervention / Treatment: Procedure: Nurse-led femoral nerve block

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Tonsberg, Norway, 3103
    • Sykehuset i Vestfold HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse-led femoral nerve block; Trained nurses in ED provide ultrasound guided single-shot femoral nerve block shortly after (at arrival emergency department) the patient is diagnosed with a hip fracture. Drug: Ropivacaine 3 mg/kg, single-shot	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)
Active Comparator: Standard of care; Nurses do not provide ultrasound guided single-shot FNB and the patient follows the standard of care course.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of total morphine equivalents - Hospital stay	Number of total morphine equivalents, mg (iv/po) administered during total hospital stay.	approx. 6 days
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Time from admission to surgery starts	Time from admission to surgery starts, minutes	approx. 48 hours
Length of total hospital stay	Length of total hospital stay, days	Approx. 6 days
Mortality during hospitalization	Mortality during hospitalization, Yes or no	Approx. 6 days
Mortality 30 days	Mortality at postoperative day 30, Yes or no	30 days
Hospital acquired pneumonia	Hospital acquired pneumonia during hospital stay, Yes or no	Approx 6 days
Acute myocardial infarction	Acute myocardial infarction during hospital stay, Yes or no	Approx 6 days
Acute renal failure	Acute renal failure during hospital stay, Yes or no	Approx 6 days
Respiratory failure	Respiratory failure during hospital stay, Yes or no	Approx 6 days
Intravasal injection	Intravasal injection - visually + circulatory and neurological symptoms, Yes or no	24 hours
Hematoma	Hematoma - defined as a new tumor > 2 centimeter in the groin / injection site measured by ultrasound, Yes or no	24 hours
Neurologic systemic outcomes / symptoms / paresthesia	Neurologic systemic outcomes / symptoms / paresthesia that have occurred after admission and which persist until discharge, numbers	Approx 6 days

Collaborators and Investigators

• Sponsor: Espen Lindholm
• Collaborators: University College of Southeast Norway
• Investigators: Principal Investigator: Elin Saga, nurse, The Hospital of Vestfold

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Nurse-led; femoral nerve block; Ultrasound guided
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Disease Attributes; Femoral Fractures; Hip Injuries; Emergencies; Fractures, Bone; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: URGENT 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan at this moment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No