How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block
NCT ID: NCT04659395
Last Updated: 2020-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
5 participants
INTERVENTIONAL
2019-09-19
2020-11-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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;
1. describe a methodology for a training course for nurse led UGFNB.
2. evaluate if the training process resulted in a safe and successful UGFNB.
Data which will be collected are
1. ASA classification (ASA Physical Status Classification System )
2. Length of stay
3. Morbidity
* Hospital acquired pneumonia
* Acute myocardial infarction (AMI)
* Acute renal failure
* Respiratory failure
4. 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
5. Number of total morphine equivalents, mg (iv/po) administered prehospital and during Emergency Department stay
6. 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Emergency nurses
Emergency nurses who are trained in an one-day course
Emergency nurses
Emergency nurses who are trained for one-day in ultrasound-guided femoral nerve block
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Emergency nurses
Emergency nurses who are trained for one-day in ultrasound-guided femoral nerve block
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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%.
Exclusion Criteria
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of South-Eastern Norway
OTHER
Sykehuset i Vestfold HF
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Espen Lindholm
Consultant
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elin saga, Nurse
Role: PRINCIPAL_INVESTIGATOR
The Hospital of Vestfold
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vestfold Hospital Trust
Tønsberg, , Norway
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Mandy, 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.
Layzell 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
533039
Identifier Type: -
Identifier Source: org_study_id