FORELEG: Effect of the Early Ultrasound-guided Femoral Nerve Block Performed by Emergency Physicians on Pre-operative Opioids Usage in Patients With Proximal Femoral Fractures
Study Details
Study Description
Brief Summary
In France, approximately 80,000 patients with a fracture of the upper extremity of the femur (femoral neck or trochanter) are admitted via emergency services. This is a serious pathology with a one-year mortality rate of 29% (i.e., 1 in 5 women and 1 in 3 men), and significant consequences on quality of life and autonomy. The morbidity of these fractures is closely related to the occurrence of confusional states or delirium before and after surgery. The diagnosis is based on clinical and radiographic views of the pelvis and the traumatized hip. These fractures are associated with severe pain, both pre- and postoperatively.
For emergency physicians, appropriate management of post-traumatic pain in these patients on arrival is a common problem. Proper pain management is essential not only 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 and independence as quickly as possible, while minimizing surgical complications and medical decompensation. However, the intense pain induced by the fracture may itself lead to an acute alteration of their mental state or a delirious state.In France, the latest formalized expert recommendations on sedation and analgesia in emergency medicine reported that local anesthesia and loco-regional anesthesia (LRA) are useful and should be promoted in emergency medicine. In 2010, the experts proposed to make 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 block was likely to be at least as effective as, if not superior to, standard analgesic practices in decreasing pain after ESF fracture.
In light of these data, the authors of the meta-analysis suggested the superiority of ultrasound guidance over anatomic location techniques or the use of neurostimulation for proper needle placement. Despite the increasing availability of ultrasound scanners in the emergency department, recent literature supporting the efficacy of echo-guided femoral block, and the evolution of clinical ultrasound skills in routine emergency medicine practice, the literature lacks data on duration of action, drug impact, and impact on the occurrence of complications when echo-guided femoral block analgesia is used early by emergency physicians.
For patients with ESF fractures, is ultrasound-guided femoral block analgesia in the emergency department more effective than intravenous morphine titration in reducing opioid use before surgery? Investigator's hypothesis is that early performance of echo-guided femoral block in the emergency department by emergency physicians decreases preoperative opioid use (intravenous and/or oral) in patients with ESF fractures.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard pain management Patients receive standard analgesic treatment, in accordance with the latest recommendations of learned societies: 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 receive standard analgesic treatment, in accordance with the latest recommendations of learned societies 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.
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| Experimental: Femoral nerve block Patients undergo femoral nerve anesthesia using the approach described in Appendix 8, under strict aseptic conditions, immediately after oral informed consent is obtained, and performed under ultrasound guidance by the emergency physician. After the femoral nerve block is performed, the patient is monitored and scoped (BP, HR, SpO2, ECG) for 90 minutes. |
Other: Femoral nerve block
Patients undergo femoral nerve anesthesia using the approach described in Appendix 8, under strict aseptic conditions, immediately after oral informed consent is obtained, and performed under ultrasound guidance by the emergency physician. After the femoral nerve block is performed, the patient is monitored and scoped (BP, HR, SpO2, ECG) for 90 minutes.
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Outcome Measures
Primary Outcome Measures
- Advantage of the echo-guided femoral nerve block [Day 2]
This outcome corresponds to the absolute difference in opioid consumption (intravenous or oral) during the first 48 hours of management between a group of patients receiving standard pain management (SPN) and a group of patients receiving femoral nerve block (FNB).
Secondary Outcome Measures
- Evaluate the benefit of early implementation of FNB on reducing time to pain control after emergency triage [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.
- Evaluate the benefit of early implementation of FNB on reducing time to standing after surgery [Hours 72]
This outcome corresponds to the difference between groups in the time (hours) between surgery and standing.
- Evaluate the benefit of early implementation of the FNB on reducing overall opioid use (IV and/or PO) during the hospital stay [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.
- 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]
This outcome corresponds to the difference between the groups in the occurrence of opioid-related complications, overall, intravenous or per os during the hospital stay, and their description, between the two groups i.e.: urinary retention, acute alteration of mental status, delirium, dyspnea and/or desaturation ≤ 92%, nausea and/or vomiting and/or constipation requiring treatment, a fall.
- 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]
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? Very easy Somewhat easy Undecided Somewhat difficult 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) Very easy Somewhat easy Undecided Somewhat difficult Very difficult
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient whose age is ≥ 18 years
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Patient with a suspected ESF fracture on emergency triage, defined as direct trauma to a hip or fall associated with hip pain and/or clinostatism and/or lower extremity deformity with, typically, shortening of the externally rotated limb
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Patient with a verbal numerical pain rating ≥ 7 on emergency triage
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Patient with a diagnosis of ESF fracture made on radiographs in the emergency department
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Patient with a normal lower extremity neurovascular examination
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Anticipated preoperative delay of at least 3 hours
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Patient affiliated to a health insurance plan
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French-speaking patient
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Patient or relative who has given free, informed and written consent
Exclusion Criteria:
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Polytrauma patient
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No surgical plan decided by the orthopedic team
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Preliminary block of the femoral nerve performed by a pre-hospital physician before arrival in the emergency room
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Patient was not walking before the fracture
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Patient has received opioids prior to ED admission (by home caregivers or as part of usual treatment) or buprenorphine or nalbuphine
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Contraindications to opioids: acute respiratory failure, acute liver failure, epilepsy not controlled by treatment, allergy; documented severe intolerance to morphine
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Contraindications to loco-regional anesthesia: constitutional or acquired coagulation disorder (anticoagulant treatment, acute hepatic insufficiency), skin infection or wound opposite the potential puncture site, acute decompensation of an underlying pathology, allergy to Ropivacaine or chlorhexidine
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Patient already included in a type 1 interventional research protocol (RIPH1)
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Patient under guardianship or curatorship
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Patient deprived of liberty
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Patient under court protection
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Pregnant or breastfeeding patient
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Groupe Hospitalier Paris Saint-Joseph | Paris | France | 75014 |
Sponsors and Collaborators
- Groupe Hospitalier Paris Saint Joseph
Investigators
- Principal Investigator: Camille GERLIER, MD, Groupe Hospitalier Paris Saint Joseph
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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. Review.
- 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.
- 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. Review.
- 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.
- 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. Review.
- FORELEG