Nurse Led Ultrasound Guided Femoral Nerve Block in the Emergency Department (URGENT)
Primary Purpose
Hip Fractures, Anesthesia, Femoral Neck Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Nurse-led femoral nerve block
Sponsored by
About this trial
This is an interventional health services research trial for Hip Fractures focused on measuring femoral nerve block, Ultrasound guided, Nurse-led
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.
Sites / Locations
- Sykehuset i Vestfold HF
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nurse-led femoral nerve block
Standard of care
Arm Description
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
Nurses do not provide ultrasound guided single-shot FNB and the patient follows the standard of care course.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Number of total morphine equivalents - Hospital stay
Number of total morphine equivalents, mg (iv/po) administered during total hospital stay.
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.
Full Information
NCT ID
NCT04145752
First Posted
October 25, 2019
Last Updated
August 30, 2021
Sponsor
Espen Lindholm
Collaborators
University College of Southeast Norway
1. Study Identification
Unique Protocol Identification Number
NCT04145752
Brief Title
Nurse Led Ultrasound Guided Femoral Nerve Block in the Emergency Department
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Espen Lindholm
Collaborators
University College of Southeast Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Anesthesia, Femoral Neck Fractures
Keywords
femoral nerve block, Ultrasound guided, Nurse-led
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, controlled, open label trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nurse-led femoral nerve block
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Nurses do not provide ultrasound guided single-shot FNB and the patient follows the standard of care course.
Intervention Type
Procedure
Intervention Name(s)
Nurse-led femoral nerve block
Intervention Description
The nurse perform a femoral nerve block in the emergency department in patients diagnosed with a hip fracture (x-ray)
Primary Outcome Measure Information:
Title
Cumulative dynamic pain score - Numerical Rating Scale (NRS) - during passive movement at 120 minutes after start of procedure
Description
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.
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Number of total morphine equivalents - 24h
Description
Number of total morphine equivalents, mg (iv/po) administered during first 24 hours from admission at the emergency department
Time Frame
24 hours
Title
Number of total morphine equivalents - Hospital stay
Description
Number of total morphine equivalents, mg (iv/po) administered during total hospital stay.
Time Frame
approx. 6 days
Title
Cumulative rest pain score -Numerical Rating Scale (NRS) - at 120 minutes after start of procedure
Description
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.
Time Frame
120 minutes
Other Pre-specified Outcome Measures:
Title
Incidence of delirium during hospital stay.
Description
Incidence of delirium, measured by Assessment test for delirium & cognitive impairment - 4AT, will be performed daily during hospital stay, number of patients
Time Frame
Approx. 6 days
Title
RASS-score - Richmond Agitation and Sedation Scale
Description
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).
Time Frame
Daily - approx. 6 days
Title
Number of (mg) administered of antiemetics during hospital stay
Description
Number of (mg) administered of antiemetics ( ondansetron, dexagalen, metoclopramide) during first 24 hours and during hospital stay.
Time Frame
approx. 6 days
Title
Time (minutes) to perform an ultrasound guided femoral nerve block performed
Description
Time (minutes) used to perform an ultrasound guided femoral nerve block performed by nurses.
Time Frame
approx 30 minutes
Title
Time from arrival at the emergency department to femoral nerve block is performed
Description
Time (min.) from arrival at emergency department (from Radiological Department) to femoral nerve block is performed.
Time Frame
Approx 1 hour
Title
Time from admission to surgery starts
Description
Time from admission to surgery starts, minutes
Time Frame
approx. 48 hours
Title
Length of total hospital stay
Description
Length of total hospital stay, days
Time Frame
Approx. 6 days
Title
Mortality during hospitalization
Description
Mortality during hospitalization, Yes or no
Time Frame
Approx. 6 days
Title
Mortality 30 days
Description
Mortality at postoperative day 30, Yes or no
Time Frame
30 days
Title
Hospital acquired pneumonia
Description
Hospital acquired pneumonia during hospital stay, Yes or no
Time Frame
Approx 6 days
Title
Acute myocardial infarction
Description
Acute myocardial infarction during hospital stay, Yes or no
Time Frame
Approx 6 days
Title
Acute renal failure
Description
Acute renal failure during hospital stay, Yes or no
Time Frame
Approx 6 days
Title
Respiratory failure
Description
Respiratory failure during hospital stay, Yes or no
Time Frame
Approx 6 days
Title
Intravasal injection
Description
Intravasal injection - visually + circulatory and neurological symptoms, Yes or no
Time Frame
24 hours
Title
Hematoma
Description
Hematoma - defined as a new tumor > 2 centimeter in the groin / injection site measured by ultrasound, Yes or no
Time Frame
24 hours
Title
Neurologic systemic outcomes / symptoms / paresthesia
Description
Neurologic systemic outcomes / symptoms / paresthesia that have occurred after admission and which persist until discharge, numbers
Time Frame
Approx 6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elin Saga, nurse
Organizational Affiliation
The Hospital of Vestfold
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset i Vestfold HF
City
Tonsberg
ZIP/Postal Code
3103
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan at this moment
Citations:
PubMed Identifier
33238043
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.
Results Reference
derived
Learn more about this trial
Nurse Led Ultrasound Guided Femoral Nerve Block in the Emergency Department
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