Femoral FractureFORELEGNCT05515718

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 study testing Standard pain management and Femoral nerve block in people with Femoral Fracture and Femoral Nerve Block, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Femoral Fracture, Femoral Nerve Block
What is being tested?: Standard pain management and Femoral nerve block
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteFrance
Study dates: 7 Sep 2022to 31 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

Patient affiliated to a health insurance plan
French-speaking patient
Patient or relative who has given free, informed and written consent

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

France1 site

Groupe Hospitalier Paris Saint-Joseph
Paris, 75014

Other trials in France

About this study

Official title: 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.

Conditions: Femoral Fracture, Femoral Nerve Block
Being tested: Standard pain management, Femoral nerve block
Medical subject headings: Femoral Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard pain managementOther
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 blockOther
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.

Study groups in NCT05515718
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Femoral nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Day 2

Secondary outcomes (5)

Evaluate the benefit of early implementation of FNB on reducing time to pain control after emergency triage
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.
Measured: Day 1
Evaluate the benefit of early implementation of FNB on reducing time to standing after surgery
This outcome corresponds to the difference between groups in the time (hours) between surgery and standing autonomously.
Measured: Hours 72
Evaluate the benefit of early implementation of the FNB on reducing overall opioid use (IV and/or PO) during the hospital stay
This outcome corresponds to the difference between the groups in overall, intravenous or oral opioid use (mg) between emergency department triage and hospital discharge.
Measured: 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)
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.
Measured: 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
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.
1. About ultrasound guidance How would you rate the ease of locating the femoral nerve and injection site on ultrasound?
2. Very easy
3. Somewhat easy
4. Undecided
5. Somewhat difficult
6. 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)
7. Very easy 2. Somewhat easy 3. Undecided 4. Somewhat difficult 5. Very difficult
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Sep 202231 Dec 2022

First posted25 Aug 2022
Study start7 Sep 2022
Primary completion31 Dec 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Femoral FractureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05515718
Sponsor's protocol ID: FORELEG
Acronym: FORELEG
Status last verified: Nov 2023
First submitted: 17 Aug 2022
Last updated: 6 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 18653186
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.
PubMed 15542989
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.
PubMed 23992774
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.
PubMed 26354332
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.
PubMed 19690943
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.
PubMed 20015246
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.
PubMed 17413915
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.
PubMed 23758305
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.
PubMed 37650732

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Enrolling by invitationObservational study
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Osteoporosis

All Femoral Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05515718
Acronym / sponsor ID: FORELEG / FORELEG
Conditions: Femoral Fracture, Femoral Nerve Block
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Fondation Hôpital Saint-JosephUniversity, hospital or other
Study start: 7 Sep 2022 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 25 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard pain management	Active comparator	Other: Standard pain managementPatients 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.
Femoral nerve block	Experimental	Other: Femoral nerve blockPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard pain managementPatients 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.	Other	Standard pain management
Femoral nerve blockPatients 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.	Other	Femoral nerve block

Primary outcome

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).

5 secondary outcomes

Evaluate the benefit of early implementation of FNB on reducing time to pain control after emergency triage
Time frame: Day 1
Evaluate the benefit of early implementation of FNB on reducing time to standing after surgery
Time frame: 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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
Background: PubMed 18653186Haleem 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.
Background: PubMed 15542989Gerson 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.
Background: PubMed 23992774Inouye 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.
Background: PubMed 26354332Riddell 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.
Background: PubMed 19690943Mouzopoulos 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.
Background: PubMed 20015246Holdgate 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.
Background: PubMed 17413915Foss 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.
Background: PubMed 23758305Beaudoin 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.
Results publication: PubMed 37650732Gerlier 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.
Les modalités de prise en charge des fractures du col du fémur en France de 1998 à 2009Link provided by the sponsor.

Related trials for Femoral Fracture

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Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
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Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Camille GERLIER, MD principal investigator

Fondation Hôpital Saint-Joseph

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standard pain management and Femoral nerve block in people with Femoral Fracture and Femoral Nerve Block, run by Fondation Hôpital Saint-Joseph at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Advantage of the echo-guided femoral nerve block (time frame: Day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05515718, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.