NCT04659395

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

November 12, 2020

Last Update Submit

December 2, 2020

Conditions

Keywords

Task shiftingUltrasound guidedTrainingEducationEmergency departmentRegistered nurseNerve blockHip fracture

Outcome Measures

Primary Outcomes (1)

  • 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.

    120 minutes

Secondary Outcomes (25)

  • Numerical Rating Scale (NRS) - during passive movement at baseline

    At baseline (timepoint 0)

  • Numerical Rating Scale (NRS) - during passive movement after 30 minutes

    After 30 minutes from baseline

  • Numerical Rating Scale (NRS) - during passive movement after 60 minutes

    After 60 minutes from baseline

  • Numerical Rating Scale (NRS) - during passive movement after 90 minutes

    After 90 minutes from baseline

  • Numerical Rating Scale (NRS) - during passive movement after 120 minutes

    After 120 minutes from baseline

  • +20 more secondary outcomes

Study Arms (1)

Emergency nurses

OTHER

Emergency nurses who are trained in an one-day course

Other: Emergency nurses

Interventions

Emergency nurses who are trained for one-day in ultrasound-guided femoral nerve block

Emergency nurses

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestfold Hospital Trust

Tønsberg, 3103, Norway

Location

Related Publications (5)

  • 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.

    PMID: 24957807BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29500558BACKGROUND
  • 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]

    BACKGROUND
  • WHO (2008). Task Shifting - Global Recommendations and Guidelines. WHO. Geneva, Switzerland., WHO Document Production Services: 96.

    BACKGROUND

MeSH Terms

Conditions

Hip FracturesAcute PainEmergencies

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Elin saga, Nurse

    The Hospital of Vestfold

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: A methodology study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

November 12, 2020

First Posted

December 9, 2020

Study Start

September 19, 2019

Primary Completion

January 30, 2020

Study Completion

November 11, 2020

Last Updated

December 9, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

No plan for sharing IPD

Locations