Effect of the Early Ultrasound-guided Femoral Nerve Block Performed by Emergency Physicians on Pre-operative Opioids Usage in Patients With Proximal Femoral Fractures
NCT ID: NCT05515718
Last Updated: 2023-12-06
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
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COMPLETED
NA
35 participants
INTERVENTIONAL
2022-09-07
2022-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Principal Investigators
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Camille GERLIER, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Hôpital Saint-Joseph
Locations
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Groupe Hospitalier Paris Saint-Joseph
Paris, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Les modalités de prise en charge des fractures du col du fémur en France de 1998 à 2009
Other Identifiers
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FORELEG
Identifier Type: -
Identifier Source: org_study_id