Hip FracturesNCT04659395
How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block
A study testing Emergency nurses in people with Hip Fractures and Ultrasound Therapy; Complications, run by Sykehuset i Vestfold HF at 1 site in Norway.
Trial summary
In this study the intervention consists of a one-day-training program for nurses and three supervised ultrasound guided femoral nerve block (UGFNB) per registered nurse. The training consists of an instruction movie, one-day on-site-simulation and practical examination. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Ultrasound Therapy; Complications, Pain, Acute
- What is being tested?
- Emergency nurses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNorway
- Study dates
- 19 Sep 2019to 11 Nov 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Registered nurses or registered nurses with continuing education in acute nursing or geriatrics
- The nurses need to be aware that it will increase the workload in beginning of the project.
- Registered nurse has to be senior staff experienced i.e. worked in the ED
- Motivated to take on a new task in the ED
- Certificated in advanced CPR
- Familiar with routines in the ED and the relevant patient group
- They must be willing to be a part of this project for approximately 12 months.
- Working at least 75%.
Who cannot join
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How to Develop a Training Program for Nurses in Ultrasound Guided Femoral - a Methodology Study
In this study the intervention consists of a one-day-training program for nurses and three supervised ultrasound guided femoral nerve block (UGFNB) per registered nurse.
The training consists of an instruction movie, one-day on-site-simulation and practical examination. The nurses are watching an instruction video and review current local guidelines for UGFNB in advance. The one-day training is situated in a simulation center and consists of theoretical and practical training divided into; infection prevention, anatomy, use of ultrasound and prevention and treatment of complications. A ultrasound model (Gen II Femoral Vascular Access and Regional Anesthesia Ultrasound Training Model) and a living human model is used to examine the femoral nerve and the neighboring structures using ultrasound. At the end of the one-day course, the nurses attends a practical examination with the researchers and anesthesiologists observing, to assure that they could perform the UGFNB procedure correctly. To pass the exam and be able to move on to the supervised blocks in real patients, there has to be a consensus between the researchers and anesthesiologist that they had sufficient knowledge and practical skills. 1) Sterile procedure 2) Management of the ultrasound machine and oral description of the anatomic surroundings in the groin area 3) Preparation of the local anesthetics and performance of an UGFNB. They also have to do an oral presentation in how they would perform a cardiopulmonary resuscitation procedure and how to manage complications / toxic reactions. Approved exam required at least seven points. This study will explore if a one-day course as described above is adequate, sufficient and maintains the safety framework of performing UGFNB in nurses
Read the detailed description
Acute pain is a common reason for patients admitted to Emergency Departments (ED) . Globally over 1 million hip fractures occur yearly , a trauma that is close related with acute distinct pain in the proximal part of the affected extremity. Experiencing severe pain is associated with increased length of stay, higher risk of delirium, movement restriction, difficulties with mobilization and reduced health related quality of life. There is considerable research regarding patients' satisfaction with their ED experiences. These studies indicate that patient dissatisfaction with the stay at ED has been an international challenge over several years . Disapproval such as; pain management , but also limited information on potential latency before further treatment and poor explanation about the causes and treatment of the condition is prominent.
Pain control can be difficult , and often requires advanced nursing and physician care due to co-morbidity . Inadequate analgesia appear to be risk factors for delirium in frail older adults, and research indicates that total avoiding opioids or using very low or high doses of opioids may increase the risk of delirium. Therefore, optimizing acute pain management is important. Ultrasound Guided Femoral Nerve block (UGFNB) performed in hip fracture patients is a valuable alternative to systemic analgesic, as it provides analgesia to the fractured area, thereby facilitating reduction in opioid administration. Traditionally, an UGFNB is performed by an anesthesiologist. Recently, several examples of task shifting from physicians to nurses are described with no significant difference in successful treatment results with equal patients satisfaction and safety as physician performed procedures. Task shifting approach is endorsed by the World Health Organization (WHO) in order to make more efficient use of the available human resource of health. A recent report from the European Union (EU) states that implementation of task shifting has been rarely evaluated and limited documented. Therefore, we need studies to examine the methodology in how we can train nurses in the ED to take more responsibility for assessing and treating patients.
In the study we aime to;
- describe a methodology for a training course for nurse led UGFNB.
- evaluate if the training process resulted in a safe and successful UGFNB.
Data which will be collected are
- ASA classification (ASA Physical Status Classification System )
- Length of stay
- Morbidity
- Hospital acquired pneumonia
- Acute myocardial infarction (AMI)
- Acute renal failure
- Respiratory failure
- Complication rate, number of;
- intravasal injection - visually + circulatory and neurological symptoms
- hematoma - defined as a new tumor > 2 cm in the groin / injection site measured by ultrasound
- Neurologic systemic outcomes / symptoms / paresthesia that have occurred after admission and which persist until discharge.
- Allergic reaction
- Number of total morphine equivalents, mg (iv/po) administered prehospital and during Emergency Department stay
- Patients physical characteristic (physical examination; gender, age, height, weight, , blood pressure, heart rate, SpO2 (oxygen saturation) and use of oxygen will be noted together with current disease
A short, but personal interview with the patients having received an UGFNB by a study nurse can describe both the service received and the patient's experience with it. The interviews will be performed after the patient has been relieved of pain. The PhD (Philosophiae Doctor)-candidate, not the study nurse having performed the nerve block, will conduct the interviews. The patients will be asked whether the nerve block relieved them of pain, how they experienced the procedure and the fact that it was performed by a nurse had any relevance. Also, the PhD-candidate will interview the patient at a later point during the hospital stay for a second time to compare the answers
The study nurses and the anesthesiologists that has supervised the nurses will be presented with a questionnaire after each UGFNB conducted. The PhD-candidate will hand out the questionnaire immediately after the FNB is conducted by a study nurse. The items in the questionnaire include feasibility and success of the procedure and are identical for nurses and anesthesiologists.
Finally, each study nurse will do three UGFNB with supervision by an anesthesiologist before we start inclusion in a later randomized controlled trial. Five study nurses will be included and fifteen patients.
The inclusion criteria for patients will be:
- Patients arriving at the ED diagnosed with a hip fracture (radiological confirmed)
- ASA- classification 1-4
- Written and verbal informed consent by patient
Exclusion criteria for patients will be:
- Patients with; dementia, without ability to give informed consent and other cognitively challenges needed to participate in this study (at the discretion of the study nurse)
- Known allergies to local anesthetic (Ropivacaine) used in UGFNB
- Use of anticoagulants or platelet inhibitors. Acetylsalicylic acid and dipyridamole is allowed. If a recent (last 2 hours) INR( international normalized ratio) is below <1.5 the patient can be included.
- Pregnant
- Age <18 years
- Severe head injury which leads to significant loss of consciousness (GCS <12)
- >10 mg or more morphine administrated pre-hospital
- Skin lesions/infection at presumed block site
- Patients admitted with other suspected or verified fractures, except small fractures in hands and foots.
Verbal and written informed consent The study nurses will inform the patients by oral and written information and inclusion and intervention of the patient will start after written consent.
- Being tested
- Emergency nurses
- Keywords
- Task shifting, Ultrasound guided, Training, Education, Emergency department, Registered nurse, Nerve block, Hip fracture
- Medical subject headings
- Hip Fractures, Acute Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency nursesOther
Emergency nurses who are trained for one-day in ultrasound-guided femoral nerve block
| Study group | Role | What they receive |
|---|---|---|
| Emergency nurses | Other | Emergency nurses who are trained in an one-day course Receives: Other: Emergency nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Numerical Rating Scale (NRS) - during passive movement at 120 minutes after start of procedure, measured by 5 timepoints
Cumulative 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 (25)
Numerical Rating Scale (NRS) - during passive movement at baseline
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 baseline (inclution of patient) NRS score: 0 is no pain and 10 is the worst pain.
Measured: At baseline (timepoint 0)
Numerical Rating Scale (NRS) - during passive movement after 30 minutes
Numerical Rating Scale (NRS) - during passive movement (30 degree flexion in the fractured hip) in patients with hip fracture during stay in the ED after 30 minutes from baseline NRS score: 0 is no pain and 10 is the worst pain.
Measured: After 30 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement after 60 minutes
Numerical Rating Scale (NRS) - during passive movement (30 degree flexion in the fractured hip) in patients with hip fracture during stay in the ED after 60 minutes from baseline NRS score: 0 is no pain and 10 is the worst pain.
Measured: After 60 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement after 90 minutes
Numerical Rating Scale (NRS) - during passive movement (30 degree flexion in the fractured hip) in patients with hip fracture during stay in the ED after 90 minutes from baseline NRS score: 0 is no pain and 10 is the worst pain.
Measured: After 90 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement after 120 minutes
Numerical Rating Scale (NRS) - during passive movement (30 degree flexion in the fractured hip) in patients with hip fracture during stay in the ED after 120 minutes from baseline NRS score: 0 is no pain and 10 is the worst pain.
Measured: After 120 minutes from baseline
Hematoma
Hematoma - defined as a new tumor > 2 centimeter in the groin / injection site measured by ultrasound, Yes or no
Measured: 24 hours
Intravasal injection
Intravasal injection - visually + circulatory and neurological symptoms, yes or no
Measured: 24 hours
Patient experience- description of pain
Patient experience of pain- During rest and motion measured by a 1-5 scale
Measured: 24 hours
Patient satisfaction- waiting time to pain relief
Patiens experiences on waiting time to pain relief measured in a scale form 1-5
Measured: 24 hours
Patient satisfaction- information
Patient experiences on information measured in a scale form 1-5
Measured: 24 hours
Patient satisfaction- description of pain before the procedure
Patient experience on pre-procedure pain measured by 1-5 scale
Measured: 24 hours
Patient satisfaction- description of pain after the procedure
Patient satisfaction- description of pain after the procedure measured by 1-5 scale
Measured: 24 hours
Patient satisfaction- safety
Patient satisfaction- description of patient reported feeling of safety during nurse led procedure measured by a 1-5 scale
Measured: 24 hours
Patient satisfaction-effect of procedure
Patient satisfaction regarding reduction of pain after the procedure measured by a 1-5 scale
Measured: 24 hours
Patient satisfaction-hearing status
Patient satisfaction hearing status measured by a 1-4 scale
Measured: 24 hours
Self reported-registered nurse- complexity
Complexity of procedure measured by scale 1-5
Measured: approximately 2 hours
Self reported-registered nurse-success
Success of procedure measured by 1-5 scale
Measured: approximately 2 hours
Self reported-registered nurse-Recognition of anatomic structures
Recognition of anatomic structures at ultrasound, measured by a 1-4
Measured: approximately 2 hours
Self reported-registred nurse-spread of anesthesia
Spread of anesthesia, measured by a 1-4 scale
Measured: approximately 2 hours
Self reported-registered nurse- patient benefit from procedure
Patient benefit of procedure measured by a 1-5 scale
Measured: approximately 2 hours
Self reported-Anesthesiologist-complexity
Complexity of procedure measured by scale 1-5
Measured: approximately 2 hours
Self reported-Anesthesiologist-success
Success of procedure measured by a 1-5 scale
Measured: approximately 2 hours
Self reported-Anesthesiologist-Recognition of anatomic structures
Recognition of anatomic structures at ultrasound measured by a 1-4 scale
Measured: approximately 2 hours
Self reported-Anesthesiologist-spread of anesthesia
Spread of anesthesia, measured by a 1-4 scale
Measured: approximately 2 hours
Self reported-Anesthesiologist-Patient benefit of procedure
Patient benefit of procedure measured by a 1-5 scale
Measured: approxemitely 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start19 Sep 2019
- Primary completion30 Jan 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Not applicable
- Intervention model
- Single group
- Model description
- A methodology study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- University of South-Eastern Norway
- Responsible party
- Principal investigator, Espen Lindholm, Sykehuset i Vestfold HF
- Investigators
- Elin saga, Nurse, Principal investigator, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659395
- Sponsor's protocol ID
- 533039
- Status last verified
- Dec 2020
- First submitted
- 12 Nov 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for sharing IPD
Publications
Dochez E, van Geffen GJ, Bruhn J, Hoogerwerf N, van de Pas H, Scheffer G. Prehospital administered fascia iliaca compartment block by emergency medical service nurses, a feasibility study. Scand J Trauma Resusc Emerg Med. 2014 Jun 23;22:38. doi: 10.1186/1757-7241-22-38.
PubMed 24957807Mandy, L. . Nurse-led femoral nerve service for patients with fractured neck of femur. Advanced Nursing Practice in Pain Management. C. E. e. al., John wiley and sons: (2009)16.
Ketelaars R, Stollman JT, van Eeten E, Eikendal T, Bruhn J, van Geffen GJ. Emergency physician-performed ultrasound-guided nerve blocks in proximal femoral fractures provide safe and effective pain relief: a prospective observational study in The Netherlands. Int J Emerg Med. 2018 Mar 2;11(1):12. doi: 10.1186/s12245-018-0173-z.
PubMed 29500558Layzell M. Nurse-led femoral nerve block service for patients with fractured neck of femur. 2010 05.02.18. In: Advancing nursing practice in pain management [Internet]. Chichester, West Sussex; Ames, Iowa: Blackwell Pub.; [16]
WHO (2008). Task Shifting - Global Recommendations and Guidelines. WHO. Geneva, Switzerland., WHO Document Production Services: 96.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Develop a Training Program for Nurses in Ultrasound Guided Femoral - a Methodology Study
- ClinicalTrials.gov ID
- NCT04659395
- Acronym / sponsor ID
- 533039
- Keywords
- Task shifting, Ultrasound guided, Training, Education, Emergency department, Registered nurse, Nerve block, Hip fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- University of South-Eastern Norway
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 9 Dec 2020 (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.
In this study the intervention consists of a one-day-training program for nurses and three supervised ultrasound guided femoral nerve block (UGFNB) per registered nurse.
The training consists of an instruction movie, one-day on-site-simulation and practical examination. The nurses are watching an instruction video and review current local guidelines for UGFNB in advance. The one-day training is situated in a simulation center and consists of theoretical and practical training divided into; infection prevention, anatomy, use of ultrasound and prevention and treatment of complications. A ultrasound model (Gen II Femoral Vascular Access and Regional Anesthesia Ultrasound Training Model) and a living human model is used to examine the femoral nerve and the neighboring structures using ultrasound. At the end of the one-day course, the nurses attends a practical examination with the researchers and anesthesiologists observing, to assure that they could perform the UGFNB procedure correctly. To pass the exam and be able to move on to the supervised blocks in real patients, there has to be a consensus between the researchers and anesthesiologist that they had sufficient knowledge and practical skills. 1) Sterile procedure 2) Management of the ultrasound machine and oral description of the anatomic surroundings in the groin area 3) Preparation of the local anesthetics and performance of an UGFNB. They also have to do an oral presentation in how they would perform a cardiopulmonary resuscitation procedure and how to manage complications / toxic reactions. Approved exam required at least seven points. This study will explore if a one-day course as described above is adequate, sufficient and maintains the safety framework of performing UGFNB in nurses
Detailed description
Acute pain is a common reason for patients admitted to Emergency Departments (ED) . Globally over 1 million hip fractures occur yearly , a trauma that is close related with acute distinct pain in the proximal part of the affected extremity. Experiencing severe pain is associated with increased length of stay, higher risk of delirium, movement restriction, difficulties with mobilization and reduced health related quality of life. There is considerable research regarding patients' satisfaction with their ED experiences. These studies indicate that patient dissatisfaction with the stay at ED has been an international challenge over several years . Disapproval such as; pain management , but also limited information on potential latency before further treatment and poor explanation about the causes and treatment of the condition is prominent.
Pain control can be difficult , and often requires advanced nursing and physician care due to co-morbidity . Inadequate analgesia appear to be risk factors for delirium in frail older adults, and research indicates that total avoiding opioids or using very low or high doses of opioids may increase the risk of delirium. Therefore, optimizing acute pain management is important. Ultrasound Guided Femoral Nerve block (UGFNB) performed in hip fracture patients is a valuable alternative to systemic analgesic, as it provides analgesia to the fractured area, thereby facilitating reduction in opioid administration. Traditionally, an UGFNB is performed by an anesthesiologist. Recently, several examples of task shifting from physicians to nurses are described with no significant difference in successful treatment results with equal patients satisfaction and safety as physician performed procedures. Task shifting approach is endorsed by the World Health Organization (WHO) in order to make more efficient use of the available human resource of health. A recent report from the European Union (EU) states that implementation of task shifting has been rarely evaluated and limited documented. Therefore, we need studies to examine the methodology in how we can train nurses in the ED to take more responsibility for assessing and treating patients.
In the study we aime to;
- describe a methodology for a training course for nurse led UGFNB.
- evaluate if the training process resulted in a safe and successful UGFNB.
Data which will be collected are
- ASA classification (ASA Physical Status Classification System )
- Length of stay
- Morbidity
- Hospital acquired pneumonia
- Acute myocardial infarction (AMI)
- Acute renal failure
- Respiratory failure
- Complication rate, number of;
- intravasal injection - visually + circulatory and neurological symptoms
- hematoma - defined as a new tumor > 2 cm in the groin / injection site measured by ultrasound
- Neurologic systemic outcomes / symptoms / paresthesia that have occurred after admission and which persist until discharge.
- Allergic reaction
- Number of total morphine equivalents, mg (iv/po) administered prehospital and during Emergency Department stay
- Patients physical characteristic (physical examination; gender, age, height, weight, , blood pressure, heart rate, SpO2 (oxygen saturation) and use of oxygen will be noted together with current disease
A short, but personal interview with the patients having received an UGFNB by a study nurse can describe both the service received and the patient's experience with it. The interviews will be performed after the patient has been relieved of pain. The PhD (Philosophiae Doctor)-candidate, not the study nurse having performed the nerve block, will conduct the interviews. The patients will be asked whether the nerve block relieved them of pain, how they experienced the procedure and the fact that it was performed by a nurse had any relevance. Also, the PhD-candidate will interview the patient at a later point during the hospital stay for a second time to compare the answers
The study nurses and the anesthesiologists that has supervised the nurses will be presented with a questionnaire after each UGFNB conducted. The PhD-candidate will hand out the questionnaire immediately after the FNB is conducted by a study nurse. The items in the questionnaire include feasibility and success of the procedure and are identical for nurses and anesthesiologists.
Finally, each study nurse will do three UGFNB with supervision by an anesthesiologist before we start inclusion in a later randomized controlled trial. Five study nurses will be included and fifteen patients.
The inclusion criteria for patients will be:
- Patients arriving at the ED diagnosed with a hip fracture (radiological confirmed)
- ASA- classification 1-4
- Written and verbal informed consent by patient
Exclusion criteria for patients will be:
- Patients with; dementia, without ability to give informed consent and other cognitively challenges needed to participate in this study (at the discretion of the study nurse)
- Known allergies to local anesthetic (Ropivacaine) used in UGFNB
- Use of anticoagulants or platelet inhibitors. Acetylsalicylic acid and dipyridamole is allowed. If a recent (last 2 hours) INR( international normalized ratio) is below <1.5 the patient can be included.
- Pregnant
- Age <18 years
- Severe head injury which leads to significant loss of consciousness (GCS <12)
- >10 mg or more morphine administrated pre-hospital
- Skin lesions/infection at presumed block site
- Patients admitted with other suspected or verified fractures, except small fractures in hands and foots.
Verbal and written informed consent The study nurses will inform the patients by oral and written information and inclusion and intervention of the patient will start after written consent.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A methodology study
| Arm | Type | Receives |
|---|---|---|
| Emergency nurses | Other | Other: Emergency nursesEmergency nurses who are trained in an one-day course |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Registered nurses or registered nurses with continuing education in acute nursing or geriatrics
- The nurses need to be aware that it will increase the workload in beginning of the project.
- Registered nurse has to be senior staff experienced i.e. worked in the ED
- Motivated to take on a new task in the ED
- Certificated in advanced CPR
Key exclusion criteria (1 listed)
- Refuse to participate
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 |
|---|---|---|
| Emergency nursesEmergency nurses who are trained for one-day in ultrasound-guided femoral nerve block | Other | Emergency nurses |
Primary outcome
Cumulative Numerical Rating Scale (NRS) - during passive movement at 120 minutes after start of procedure, measured by 5 timepoints
Time frame: 120 minutes
Cumulative 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.
25 secondary outcomes
Numerical Rating Scale (NRS) - during passive movement at baseline
Time frame: At baseline (timepoint 0)
Numerical Rating Scale (NRS) - during passive movement after 30 minutes
Time frame: After 30 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement after 60 minutes
Time frame: After 60 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement after 90 minutes
Time frame: After 90 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement after 120 minutes
Time frame: After 120 minutes from baseline
Hematoma
Time frame: 24 hours
Intravasal injection
Time frame: 24 hours
Patient experience- description of pain
Time frame: 24 hours
Patient satisfaction- waiting time to pain relief
Time frame: 24 hours
Patient satisfaction- information
Time frame: 24 hours
Patient satisfaction- description of pain before the procedure
Time frame: 24 hours
Patient satisfaction- description of pain after the procedure
Time frame: 24 hours
Patient satisfaction- safety
Time frame: 24 hours
Patient satisfaction-effect of procedure
Time frame: 24 hours
Patient satisfaction-hearing status
Time frame: 24 hours
Self reported-registered nurse- complexity
Time frame: approximately 2 hours
Self reported-registered nurse-success
Time frame: approximately 2 hours
Self reported-registered nurse-Recognition of anatomic structures
Time frame: approximately 2 hours
Self reported-registred nurse-spread of anesthesia
Time frame: approximately 2 hours
Self reported-registered nurse- patient benefit from procedure
Time frame: approximately 2 hours
Self reported-Anesthesiologist-complexity
Time frame: approximately 2 hours
Self reported-Anesthesiologist-success
Time frame: approximately 2 hours
Self reported-Anesthesiologist-Recognition of anatomic structures
Time frame: approximately 2 hours
Self reported-Anesthesiologist-spread of anesthesia
Time frame: approximately 2 hours
Self reported-Anesthesiologist-Patient benefit of procedure
Time frame: approxemitely 2 hours
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 9 Dec 2020.
- Background: PubMed 24957807Dochez E, van Geffen GJ, Bruhn J, Hoogerwerf N, van de Pas H, Scheffer G. Prehospital administered fascia iliaca compartment block by emergency medical service nurses, a feasibility study. Scand J Trauma Resusc Emerg Med. 2014 Jun 23;22:38. doi: 10.1186/1757-7241-22-38.
- BackgroundMandy, L. . Nurse-led femoral nerve service for patients with fractured neck of femur. Advanced Nursing Practice in Pain Management. C. E. e. al., John wiley and sons: (2009)16.
- Background: PubMed 29500558Ketelaars R, Stollman JT, van Eeten E, Eikendal T, Bruhn J, van Geffen GJ. Emergency physician-performed ultrasound-guided nerve blocks in proximal femoral fractures provide safe and effective pain relief: a prospective observational study in The Netherlands. Int J Emerg Med. 2018 Mar 2;11(1):12. doi: 10.1186/s12245-018-0173-z.
- BackgroundLayzell M. Nurse-led femoral nerve block service for patients with fractured neck of femur. 2010 05.02.18. In: Advancing nursing practice in pain management [Internet]. Chichester, West Sussex; Ames, Iowa: Blackwell Pub.; [16]
- BackgroundWHO (2008). Task Shifting - Global Recommendations and Guidelines. WHO. Geneva, Switzerland., WHO Document Production Services: 96.
- Individual participant dataSharing planned: No. No plan for sharing IPD
Related trials for Hip Fractures
Not yet recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
RecruitingObservational study
Pelvic and Acetabular Fracture: A Prospective Observational Study
Pelvic Fracture, Acetabular Fracture
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
Trochanteric Bursa Repair and Lateral Hip Pain After Hemiarthroplasty for Femoral Neck Fracture
Femoral Neck Fracture
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 Emergency nurses in people with Hip Fractures and Ultrasound Therapy; Complications, run by Sykehuset i Vestfold HF 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 8 inclusion and 1 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 9 Dec 2020. 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 Numerical Rating Scale (NRS) - during passive movement at 120 minutes after start of procedure, measured by 5 timepoints (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 NCT04659395, which also lists 5 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 9 Dec 2020.