Effect of the Early Ultrasound-guided Femoral Nerve Block Performed by Emergency Physicians on Pre-operative Opioids Usage in Patients With Proximal Femoral Fractures (FORELEG)

November 30, 2023 updated by: Fondation Hôpital Saint-Joseph

Effect of the Early Ultrasound-guided Femoral Nerve Block Performed by Emergency Physicians on Pre-operative Opioids Usage in Patients With Proximal Femoral Fractures: a Randomized Controlled Trial

In France, approximately 80,000 patients with a fracture of the upper extremity of the femur (femoral neck or trochanter) are admitted in the emergency department. This is a serious disease with a one-year mortality rate of 29% (i.e., 1 of 5 women and 1 of 3 men), and significant consequences on quality of life and autonomy. The morbidity of these fractures is closely related to the occurrence of altered mental status or delirium, before and after surgery. The diagnosis is based on clinical features and x-rays of the hip. These fractures are associated with severe level of pain, before and after the surgery. For emergency physicians, managing appropriately the pain is a common problem at the admission in the emergency room. Proper pain management is essential to ensure patients' comfort before surgery, but also to ensure their return to their previous functional and cognitive state after surgery. For patients, the goal of treatment is to regain walking as quickly as possible, while minimizing surgical and medical complications. However, severe pain induced by the fracture may lead to an acute altered mental status or delirium. In France, the latest guidelines about analgesia in emergency medicine reported that local anesthesia and loco-regional anesthesia (LRA) are useful and should be promoted in emergency medicine. In 2010, these guidelines proposed to perform LRA techniques such as iliofascial block more widely available. In 2016, the largest review of the literature on the use of regional nerve blocks for hip and femoral neck fractures in the emergency department [MEDLINE (1946-2014), EMBASE (1947-2014), CINAHL (1960-2014), and the Cochrane Central Register of Controlled Trials] indicated that the femoral nerve block was likely to be at least as effective as, if not superior to, standard analgesic practices for decreasing pain after ESF fracture.

The authors of the meta-analysis suggested the superiority of ultrasound guidance compared to anatomic techniques or use of neurostimulation for an adequate needle placement. Despite the increasing availability of ultrasound in the emergency department, recent literature supporting the efficacy of ultrasound-guided femoral nerve block, and the improvement of ultrasound skills in routine emergency medicine practice, the literature lacks of data about the effective duration of action, medication influence, and the occurrence of complications when an ultrasound-guided femoral nerve block is used by emergency physicians at the admission.

For patients with hip fractures, it is questioned if ultrasound-guided femoral block used early on admission in the emergency room is in more efficient than intravenous morphine titration in reducing opioid use before surgery? Our hypothesis is that early use of ultrasound-guided femoral nerve block in the emergency room decreases preoperative opioid use (intravenous and/or oral) in patients with proximal femoral fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient whose age is ≥ 18 years

  • Patient with a suspicion of proximal femoral fracture at the emergency triage, defined as direct traumatism on hip or fall associated with hip pain and/or clinostatism and/or lower extremity deformity with, typically, shortening of the externally rotated limb

    • Patient with a verbal numerical pain rating ≥ 7 on emergency triage
    • Patient with a diagnosis of ESF fracture made on x-rays in the emergency department
    • Patient with a normal lower extremity neurovascular examination
    • Anticipated preoperative delay of at least 3 hours
    • Patient affiliated to a health insurance plan
    • French-speaking patient
    • Patient or relative who has given free, informed and written consent

Exclusion Criteria:

  • Patient with multiples trauma
  • No surgical treatment decided by the orthopedic team
  • Prior femoral nerve block performed during pre-hospital time
  • Patient was not walking before the fracture
  • Patient has received opioids prior to ED admission (by home caregivers or as part of usual treatment) or buprenorphine or nalbuphine
  • Contraindications to opioids: acute respiratory failure, acute liver failure, epilepsy not controlled by treatment, allergy; documented severe intolerance to morphine
  • Contraindications to loco-regional anesthesia: constitutional or acquired coagulation disorder (anticoagulant treatment, acute hepatic failure), skin infection or wound near to the potential injection site, acute failure of an underlying disease, allergy to Ropivacaine or chlorhexidine
  • Patient already included in a type 1 interventional research protocol (RIPH1)
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Pregnant or breastfeeding patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard pain management

Patients receive a standard analgesic treatment, in accordance with the latest international guidelines :

  • if pain EN is ≥ 3: Paracetamol 1g every 6 hours (age <75 years) or every 8 hours (# 75 years) and/or Tramadol 50 mg every 8 hours ;
  • and/or if verbal EN for pain is ≥ 7: intravenous morphine titration according to local protocol: 3 mg bolus if weight > 60 kg and age ≤ 80 years; Bolus of 2 mg if weight ≤ 60 kg and age ≤ 80 years ; Bolus of 1 mg if age>80 years, regardless of weight ; This bolus is repeated every 5 minutes until an EN≤ 3 is obtained.
Other: Standard pain management
Patients undergo ultrasound-guided femoral nerve blockperformed by a trained emergency physician, under strict aseptic conditions After the femoral nerve block is performed, the patient is monitored and (BP, HR, SpO2, ECG) during 90 minutes.
Experimental: Femoral nerve block

Patients receive a standard analgesic treatment, in accordance with the latest international guidelines 5,13,45: - if pain EN is ≥ 3:

Paracetamol 1g every 6 hours (age <75 years) or every 8 hours (# 75 years) and/or Tramadol 50 mg every 8 hours; - and/or if verbal EN for pain is ≥ 7: intravenous morphine titration according to local protocol: 3 mg bolus if weight > 60 kg and age ≤ 80 years; Bolus of 2 mg if weight ≤ 60 kg and age ≤ 80 years ; Bolus of 1 mg if age>80 years, regardless of weight ; This bolus is repeated every 5 minutes until an EN≤ 3 is obtained.
Other: Femoral nerve block
Patients undergo ultrasound-guided femoral nerve blockperformed by a trained emergency physician under strict aseptic conditions, immediately after oral informed consent is obtained. After the femoral nerve block is performed, the patient is monitored and (BP, HR, SpO2, ECG) during 90 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advantage of the echo-guided femoral nerve block
Time Frame: Day 2
This outcome corresponds to the absolute difference in opioid utilization (intravenous or oral) during the first 48 hours after the emergency department triage between a group of patients receiving standard pain management (SPN) and a group of patients receiving femoral nerve block (FNB).
Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the benefit of early implementation of FNB on reducing time to pain control after emergency triage
Time Frame: Day 1
This outcome corresponds to the difference between the groups the time (minutes) from emergency department triage to obtaining a verbal Numerical Pain Scale (NPS) ≤ 3 out of 10 at rest and in motion.
Day 1
Evaluate the benefit of early implementation of FNB on reducing time to standing after surgery
Time Frame: Hours 72
This outcome corresponds to the difference between groups in the time (hours) between surgery and standing autonomously.
Hours 72
Evaluate the benefit of early implementation of the FNB on reducing overall opioid use (IV and/or PO) during the hospital stay
Time Frame: Day 30
This outcome corresponds to the difference between the groups in overall, intravenous or oral opioid use (mg) between emergency department triage and hospital discharge.
Day 30
Evaluate the benefit of early implementation of FNB on reducing the occurrence of complications related to overall opioid use (intravenous and/or per os)
Time Frame: Day 30
This outcome corresponds to the difference between the groups in the occurrence of opioid-related complications, overall, intravenous or per os during the hospital length of stay, and their description, between the two groups i.e.: urinary retention, acute altered mental mental status, delirium, dyspnea and/or desaturation ≤ 92%, nausea and/or vomiting and/ or constipation requiring treatment, a fall.
Day 30
Evaluate the difficulty experienced by the emergency physician for the ultrasound location of the femoral nerve and for the injection technique of the local anesthetic
Time Frame: Day 1

This outcome corresponds to the difficulty measured on a 5-point Likert scale for the ultrasound location of the femoral nerve and for the injection technique of the local anesthetic.

A. About ultrasound guidance How would you rate the ease of locating the femoral nerve and injection site on ultrasound?

  1. Very easy
  2. Somewhat easy
  3. Undecided
  4. Somewhat difficult
  5. Very difficult B. About local anesthesia How would you rate the ease of the local anesthetic injection technique (needle location, aspiration test, local anesthetic injection)

1. Very easy 2. Somewhat easy 3. Undecided 4. Somewhat difficult 5. Very difficult
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Hôpital Saint-Joseph

Investigators

  • Principal Investigator: Camille GERLIER, MD, Fondation Hôpital Saint-Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FORELEG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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