Hip FracturesURGENTNCT04145752
Nurse Led Ultrasound Guided Femoral Nerve Block in the Emergency Department
A study testing Nurse-led femoral nerve block in people with Hip Fractures and Anesthesia, run by Espen Lindholm at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Hip Fractures, Anesthesia, Femoral Neck Fractures
- What is being tested?
- Nurse-led femoral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNorway
- Study dates
- 11 Feb 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- >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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hip Fractures, Anesthesia, Femoral Neck Fractures
- Being tested
- Nurse-led femoral nerve block
- Keywords
- femoral nerve block, Ultrasound guided, Nurse-led
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led femoral nerve blockProcedure or surgery
The nurse perform a femoral nerve block in the emergency department in patients diagnosed with a hip fracture (x-ray)
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led femoral nerve block | Experimental | 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 Receives: Procedure: Nurse-led femoral nerve block |
| Standard of care | Active comparator | Nurses do not provide ultrasound guided single-shot FNB and the patient follows the standard of care course. Receives: Procedure: Nurse-led femoral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes
Secondary outcomes (3)
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
Measured: 24 hours
Number of total morphine equivalents - Hospital stay
Number of total morphine equivalents, mg (iv/po) administered during total hospital stay.
Measured: 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.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start11 Feb 2020
- Primary completion30 Jun 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, open label trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Espen Lindholm
- Sponsor type
- University, hospital or other
- Collaborators
- University College of Southeast Norway
- Responsible party
- Sponsor-investigator, Espen Lindholm, Sykehuset i Vestfold HF
- Investigators
- Elin Saga, nurse, Principal investigator, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145752
- Sponsor's protocol ID
- URGENT 2019
- Acronym
- URGENT
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2019
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan at this moment
Publications
Saga E, Falk RS, Bing-Jonsson PC, Skovdahl KI, Lindholm E. Nurse-led ultrasound-guided femoral nerve block: A randomised controlled trial of two different patient flow systems in an emergency department. Int J Orthop Trauma Nurs. 2024 Feb;52:101074. doi: 10.1016/j.ijotn.2023.101074. Epub 2023 Dec 4.
PubMed 38070309Guay 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.
PubMed 33238043
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04145752
- Acronym / sponsor ID
- URGENT / URGENT 2019
- Conditions
- Hip Fractures, Anesthesia, Femoral Neck Fractures
- Keywords
- femoral nerve block, Ultrasound guided, Nurse-led
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Espen LindholmUniversity, hospital or other
- Collaborators
- University College of Southeast Norway
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, open label trial
| Arm | Type | Receives |
|---|---|---|
| Nurse-led femoral nerve block | Experimental | Procedure: Nurse-led femoral nerve blockTrained 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 |
| Standard of care | Active comparator | Procedure: Nurse-led femoral nerve blockNurses do not provide ultrasound guided single-shot FNB and the patient follows the standard of care course. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led femoral nerve blockThe nurse perform a femoral nerve block in the emergency department in patients diagnosed with a hip fracture (x-ray) | Procedure or surgery | Nurse-led femoral nerve block, Standard of care |
Primary outcome
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.
3 secondary outcomes
Number of total morphine equivalents - 24h
Time frame: 24 hours
Number of total morphine equivalents - Hospital stay
Time frame: approx. 6 days
Cumulative rest pain score -Numerical Rating Scale (NRS) - at 120 minutes after start of procedure
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 38070309Saga E, Falk RS, Bing-Jonsson PC, Skovdahl KI, Lindholm E. Nurse-led ultrasound-guided femoral nerve block: A randomised controlled trial of two different patient flow systems in an emergency department. Int J Orthop Trauma Nurs. 2024 Feb;52:101074. doi: 10.1016/j.ijotn.2023.101074. Epub 2023 Dec 4.
- Derived from this study: PubMed 33238043Guay 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.
- Individual participant dataSharing planned: No. No plan at this moment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elin Saga, nurse principal investigator
The Hospital of Vestfold
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led femoral nerve block in people with Hip Fractures and Anesthesia, run by Espen Lindholm at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative dynamic pain score - Numerical Rating Scale (NRS) - during passive movement at 120 minutes after start of procedure (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04145752, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.