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

NCT05515718 | Completed

• 1 other identifier: FORELEG
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Femoral Fracture; Femoral Nerve Block

Outcome Measures

Primary Outcomes (1)

• Advantage of the echo-guided femoral nerve block

  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 Outcomes (5)

• Evaluate the benefit of early implementation of FNB on reducing time to pain control after emergency triage

  Day 1

• Evaluate the benefit of early implementation of FNB on reducing time to standing after surgery

  Hours 72

• Evaluate the benefit of early implementation of the FNB on reducing overall opioid use (IV and/or PO) during the hospital stay

  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)

  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

  Day 1

Study Arms (2)

Standard pain management

ACTIVE COMPARATOR

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

Femoral nerve block

EXPERIMENTAL

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

Interventions

Standard pain management OTHER

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.

Standard pain management

Femoral nerve block OTHER

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.

Femoral nerve block

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (9)

• Haleem S, Lutchman L, Mayahi R, Grice JE, Parker MJ. Mortality following hip fracture: trends and geographical variations over the last 40 years. Injury. 2008 Oct;39(10):1157-63. doi: 10.1016/j.injury.2008.03.022. Epub 2008 Jul 24.

  PMID: 18653186 BACKGROUND

• Gerson LW, Emond JA, Camargo CA Jr. US emergency department visits for hip fracture, 1992-2000. Eur J Emerg Med. 2004 Dec;11(6):323-8. doi: 10.1097/00063110-200412000-00005.

  PMID: 15542989 BACKGROUND

• Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.

  PMID: 23992774 BACKGROUND

• Riddell M, Ospina M, Holroyd-Leduc JM. Use of Femoral Nerve Blocks to Manage Hip Fracture Pain among Older Adults in the Emergency Department: A Systematic Review. CJEM. 2016 Jul;18(4):245-52. doi: 10.1017/cem.2015.94. Epub 2015 Sep 10.

  PMID: 26354332 BACKGROUND

• Mouzopoulos G, Vasiliadis G, Lasanianos N, Nikolaras G, Morakis E, Kaminaris M. Fascia iliaca block prophylaxis for hip fracture patients at risk for delirium: a randomized placebo-controlled study. J Orthop Traumatol. 2009 Sep;10(3):127-33. doi: 10.1007/s10195-009-0062-6. Epub 2009 Aug 19.

  PMID: 19690943 BACKGROUND

• Holdgate A, Shepherd SA, Huckson S. Patterns of analgesia for fractured neck of femur in Australian emergency departments. Emerg Med Australas. 2010 Feb;22(1):3-8. doi: 10.1111/j.1742-6723.2009.01246.x. Epub 2009 Dec 14.

  PMID: 20015246 BACKGROUND

• Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2.

  PMID: 17413915 BACKGROUND

• Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013 Jun;20(6):584-91. doi: 10.1111/acem.12154.

  PMID: 23758305 BACKGROUND

• Gerlier C, Mijahed R, Fels A, Bekka S, Courseau R, Singh AL, Ganansia O, Chatellier G. Effect of early ultrasound-guided femoral nerve block on preoperative opioid consumption in emergency patients with hip fracture: a randomized trial. Eur J Emerg Med. 2024 Feb 1;31(1):18-28. doi: 10.1097/MEJ.0000000000001075. Epub 2023 Aug 24.

  PMID: 37650732 RESULT

Related Links

• Les modalités de prise en charge des fractures du col du fémur en France de 1998 à 2009

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Camille GERLIER, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 25, 2022
• Study Start: September 7, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

FR (1)