Nurse Led Ultrasound Guided Femoral Nerve Block in the Emergency Department

NCT04145752 | Completed

• 1 other identifier: URGENT 2019
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Anesthesia; Femoral Neck Fractures

Keywords

femoral nerve block; Ultrasound guided; Nurse-led

Outcome Measures

Primary Outcomes (1)

• 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.

  120 minutes

Secondary Outcomes (3)

• Number of total morphine equivalents - 24h

  24 hours

• Number of total morphine equivalents - Hospital stay

  approx. 6 days

• Cumulative rest pain score -Numerical Rating Scale (NRS) - at 120 minutes after start of procedure

  120 minutes

Other Outcomes (16)

• Incidence of delirium during hospital stay.

  Approx. 6 days

• RASS-score - Richmond Agitation and Sedation Scale

  Daily - approx. 6 days

• Number of (mg) administered of antiemetics during hospital stay

  approx. 6 days

Study Arms (2)

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

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.

Procedure: Nurse-led femoral nerve block

Interventions

Nurse-led femoral nerve block PROCEDURE

The nurse perform a femoral nerve block in the emergency department in patients diagnosed with a hip fracture (x-ray)

Nurse-led femoral nerve block; Standard of care

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Espen Lindholm: lead
• University College of Southeast Norway: collaborator

Study Sites (1)

Sykehuset i Vestfold HF

Tønsberg, 3103, Norway

Location

Related Publications (2)

• 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.

  PMID: 38070309 DERIVED

• 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.

  PMID: 33238043 DERIVED

MeSH Terms

Conditions

Hip Fractures; Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Elin Saga, nurse

  The Hospital of Vestfold

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior consultant

Model Details: Prospective, randomized, controlled, open label trial

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 31, 2019
• Study Start: February 11, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2022
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)