Femur FractureNCT06155903
Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture
A study testing Selective Spinal Anesthesia, Peripheral nerve blocks and Anesthesiological mixtures (Spinal anesthesia) in people with Femur Fracture and Peripheral Nerve Block, run by Federico II University at 1 site in Italy.
Trial summary
Proximal Femur Fractures (PFF) represent one of the most common orthopedic injuries worldwide, affecting especially elderly patients with potentially disabling outcomes and a marked impairment of quality of life. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femur Fracture, Peripheral Nerve Block, Spinal Anesthesia
- What is being tested?
- Selective Spinal Anesthesia, Peripheral nerve blocks and Anesthesiological mixtures (Spinal anesthesia)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 31 Dec 2023to 15 Jun 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
"Inclusion Criteria" :
- Subject has signed and dated an Informed Consent Form
- Subject is classified as a ASA (American Society of Anesthesiologists) status I-IV
- Subject is age over 65 years old
- Subjects with femur fracture, candidates for intramedullary nailing surgery, to be operated on within 48 hours
"Exclusion Criteria":
- Age younger than 65 years
- Subject with contraindications to subarachnoid technique or peripherical nerve blocks
- Subject with local anesthetic allergy
- Subject in whom the treatment protocol could not be fully applied were excluded from this study.
- Study refusal
- Neurological disease of the lower limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture: A Prospective Randomized Controlled Study
Proximal Femur Fractures (PFF) represent one of the most common orthopedic injuries worldwide, affecting especially elderly patients with potentially disabling outcomes and a marked impairment of quality of life. Taking into account their inherent instability, PFF are usually treated surgically within the shortest possible delay in order to reduce the risk of major and minor complications, the length of hospitalization and related costs. In this setting, most retrospective and prospective studies have reported a similar 30-day mortality rate comparing Spinal Anesthesia (SA) and General Anesthesia (GA), often recommending an adjuvant Peripheral Nerve Block (PNBs) to control postoperative pain. There is consensus that anticoagulant therapy, lack of pharmacological optimization or other conditions may represent a contraindication to SA. In these cases, blocking the nerves responsible for innervation of the proximal femur (i.e., the femoral, lateral femoral-cutaneous, obturators and sciatic nerves) may be a useful option. This study will aim to compare the incidence of intraoperative and postoperative adverse events, as well as the analgesic efficacy of the PNBs compared to SSA in patients diagnosed with PFF who underwent intramedullary nailing as a method of fixation.
Read the detailed description
A venous access (16-18 G) will be placed in the operating room and antibiotic prophylaxis will be administered (Cefazolin 1 or 2 gr. iv or, in case of allergy, Clindamycin 600 mg iv). Pantoprazole 40 mg iv will also be administered. Pulse oximetry (SpO2), heart rate (HR), body temperature (C°), continuous invasive blood pressure (cIBP), brain oximetry with ForeSight will be monitored. Risk factors of Postoperative Nausea and Vomiting (PONV) will be assessed using the Apfel score. Antiemetic prophylaxis will be administered in accordance with the 2020 Fourth Consensus Guidelines for the Management of PONV. A pre-loading will be started with 500 ml of crystalloids iv will be administered; pre-procedural sedation will be performed with Midazolam 0.03 mg/Kg until a Richmond Agitation Sedation Scale (RASS) -1 or -2 will be obtained. All patients will receive intraoperative sedation with Dexmedetomidine 0.7 gamma/Kg/h and o2-therapy with a nasal cannula with a flow rate of 2L/min. We will also proceed to an intraoperative fluid administration of 15-20 ml / kg / hour of iv crystalloids. Rate of hypotension and bradycardia will be monitored during surgery. At this point, the type of anesthesia will be followed based on the randomization group.The following variables will be evaluated:
- intraoperative haemodynamic adverse events (rates of hypotension and bradycardia)
- postoperative adverse events (rates of nausea/vomiting and delirium and rate of deep vein thrombosis, myocardial infarction and neurological lesion during the hospital stay);
- postoperative pain evaluated by NRS and PAINED
- time to mobilization
- need of analgesic rescue dose after surgery
- lenght of stay
- bromage and hollmen scale of healthy limb and fractured limb assessed at different time
- surgical satisfaction (evaluated with 6-point Likert scale).
- the duration of surgery (min)
- Conditions
- Femur Fracture, Peripheral Nerve Block, Spinal Anesthesia
- Being tested
- Selective Spinal Anesthesia, Peripheral nerve blocks, Anesthesiological mixtures (Spinal anesthesia), Anesthesiological mixtures (Peripheral nerve block)
- Keywords
- SPINAL ANESTHESIA, FEMUR FRACTURE, NERVE BLOCK, LOCOREGIONAL ANESTHESIA
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Spinal AnesthesiaProcedure or surgery
Selective Spinal Anesthesia will be performed at the L2-L3 or L3-L4 interspace with the patients lying in the lateral position (fractured side up). Anesthesiologists will determine the needling point for spinal anesthesia with reference to Tuffier's line, a virtual line connecting the tops of the iliac crests of a patient. A small dose of LA (4 ml of 1% lidocaine) will be injected into the skin and soft tissues at the planned site of spinal needle insertion. The correct path for spinal needle placement will be identified with the needle infiltration. The technique will be performed aseptically in the subarachnoid space after observing clear Cephalo-Spinal Fluid (CSF) in the spinal needle 25 Gauge, and without releasing the CSF. Selected patients will receive Hypobaric Bupivacaine 0.5% 7.5 mg and Sufentanil 5 µg and will maintain the lateral position for 15 min. At the end of these they will be gently placed in supine position.
Peripheral nerve blocksProcedure or surgery
In this group, four nerve blocks will be associated to ensure adequate anesthesia and analgesia during surgery.
Sciatic nerve blocks with para sacral approach will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the related muscles. Next, an anesthetic solution of Ropivacaine 0.375% (dose 37.5 mg) plus Mepivacaine 1% (dose 100 mg) and Dexamethasone 4mg, total volume 21 ml, will be injected.
Lateral femoral cutaneous, femoral and obturator nerve blocks, femoral will be performed with the ultrasound technique. After identifying the nerves, a needle will be inserted with an "in plane" approach and will be injected.
The anesthesia mixture will consist for all of :Ropivacaine 0.375% plus Mepivacaine 1% plus dexamethasone 4 mg.
The volumes of the 3 anesthesia mixtures will be respectively: 1ml, 15ml,5ml.
Anesthesiological mixtures (Spinal anesthesia)Drug
The anesthesia mixtures will be injected into the subarachnoid space for spinal anesthesia. It will consist of the following local anesthetics and adjuvants: Hypobaric Bupivacaine 0.5% 7.5 mg and Sufentanil 5 µg.
Anesthesiological mixtures (Peripheral nerve block)Drug
The anesthesia mixtures will be injected into selected peripheral nerves . It will consist of the following local anesthetics and adjuvants: Ropivacaine 0.375% plus Mepivacaine 1% and Dexamethasone 4 mg.
| Study group | Role | What they receive |
|---|---|---|
| Selective Spinal Anesthesia | Active comparator | The participant will receive selective spinal anesthesia. Receives: Procedure: Selective Spinal Anesthesia; Drug: Anesthesiological mixtures (Spinal anesthesia) |
| Peripheral nerve blocks | Active comparator | The participant will receive a combination of femoral nerve block, sciatic nerve block with parasacral approach, lateral femoral cutaneous nerve block and obturator nerve block. Receives: Procedure: Peripheral nerve blocks; Drug: Anesthesiological mixtures (Peripheral nerve block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain evaluated by NRS scales
NRS assessment will be carried out using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". patients will be asked to circle the number between 0 and 10 that fits best to their pain intensity.
Measured: Every 6 hours during treatment until the first 24 postoperative hours
Postoperative pain evaluated by PAINAD scales
The PAINED scale (Pain Assessment in Advanced Dementia Scale) assesses 5 items: facial expression, breathing, negative vocalizations, consolability and body language with a range from 0 to 10 (1-3=mild pain; 4-6=moderate pain; 7-10=severe pain).
Measured: Every 6 hours during treatment until the first 24 postoperative hours
Rate of postoperative nausea and vomiting (PONV)
We will analyze the risk factors of postoperative nausea and vomiting (PONV) by administering an Apfel score to each patient, practicing intraoperative and postoperative antiemetic treatment in accordance with the 2020 Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting.
Measured: Every 6 hours during treatment until the first 24 postoperative hours
Rate of Delirium
Postoperative delirium (POD) is an acute and fluctuating alteration of mental state of reduced awareness and disturbance of attention, which begins in the recovery room and occurs up to 5 days after surgery. POD will be detected by "3-Minute Diagnostic Confusion Assessment Method" (3D-CAM) and has four features: (1) altered mental status/fluctuating course, (2) inattention, (3) altered level of consciousness, and (4) disorganized thinking [27]. For the prevention and treatment of POD, we will follow the 2017 European Society of Anesthesiology guidelines.
Measured: Every 6 hours during treatment until the first 24 postoperative hours
Rate of deep vein thrombosis
The diagnosis of Deep Vein Thrombosis will be based on postoperative observations of the affected limbs during the patient's hospital stay; the following manifestations will be monitored: limb swelling, pain, elevated skin temperature, changes in skin color, venous return disorders, Homans' sign, and Neuhof's sign. Color-Doppler ultrasound will be performed bilaterally, in case of positivity of clinical signs and symptoms.
Measured: up to 1 weeks
Rate of myocardial infarction
The typical symptoms of myocardial ischemia, combined with characteristic changes on an ECG and a significant increase in blood levels of high-sensitivity cardiac troponins, will be used to diagnose a Myocardial Infarction. In cases where the diagnosis is uncertain, it will be necessary to conduct additional non-invasive evaluations, such as an echocardiogram
Measured: up to 1 weeks
Rate of neurological lesion
Neurological lesion was evaluated based on the presence of sensory, motor, or both neurological symptoms
Measured: up to 1 weeks
Intraoperative haemodynamic adverse events
Hypotension defined as a Systolic Blood Pressure (SBP) of less than 90 mm Hg for more than 5 minutes or a decrease of 35% in the Mean Arterial Pressure (MAP). Bradicardia, indicated by a heart rate of fewer than 60 beats per minute for more than 5 minutes.
Measured: From the beginning to the end of surgery
Secondary outcomes (4)
Need of analgesic rescue dose
time between anesthesia and first analgesic rescue dose.Pharmacological therapy will be based on the patients' responses. After surgery, we will administer intravenous paracetamol 1 g 3 times a day. Ketorolac 30 mg (not for glomerular filtration rate < 50 ml/min) or Oxycodone (up to 0.1mg/Kg) mg will be available as rescue dose. Pain control will be considered good in case of NRS and PAINED score less than or equal to 4.
Measured: From the end of treatment to 24 hours postoperatively
Time to mobilization (hours)
Time to mobilization (hours), defined as the time (hours) between LA injection and lower limb mobilization (score 4) on the Bromage scale (1, unable to move feet or knees; 2, able to move feet only; 3, just able to move knees; 4, full flexion of knees and feet).
Measured: Time to mobilization will be assessed immediately after the locoregional procedure, up to 24 hours postoperatively.
Lenght of stay (days)
Lenght of stay (days), defined as days from hospital admission to discharge, will be reported.
Measured: from date of hospital admission up to 1 weeks
Bromage and Hollmen scale of healthy limb and fractured limb assessed at different time
During the execution of the anesthesiologic procedures, the motor and sensory blocks will be tested bilaterally using the "Bromage scale" and with the "Hollmen scale", respectively. The presence of complete motor block (Bromage 1) with "unable to move feet or knees", and complete sensory block (Hollmen 4), tested by pinprick and ice test, defined as "loss of sensation" in the affected limb, will define an adequate anesthesiological plane.
Measured: Motor block and sensory block were assessed before LA injection (baseline time) and 10 , 15 and 20 minutes after baseline time and every 30 minute during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start31 Dec 2023
- Primary completion1 Apr 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Coviello, Federico II University
- Investigators
- Antonio Coviello, Researcher, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155903
- Sponsor's protocol ID
- 2-2023-533
- Status last verified
- May 2025
- First submitted
- 2 Jul 2023
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Coviello A, Cirillo D, Bernasconi A, de Siena AU, Spasari E, Barone MS, Piccione I, Ranieri G, Tognu A, Servillo G, Iacovazzo C. Peripheral nerve blocks vs selective spinal anesthesia in patients with femur fracture: a patient-, surgeon-, and assessor-blinded randomized controlled study. J Anesth Analg Crit Care. 2025 Dec 3;5(1):88. doi: 10.1186/s44158-025-00302-6.
PubMed 41340155
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06155903
- Acronym / sponsor ID
- 2-2023-533
- Conditions
- Femur Fracture, Peripheral Nerve Block, Spinal Anesthesia
- Keywords
- SPINAL ANESTHESIA, FEMUR FRACTURE, NERVE BLOCK, LOCOREGIONAL ANESTHESIA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 5 Dec 2023 (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.
Proximal Femur Fractures (PFF) represent one of the most common orthopedic injuries worldwide, affecting especially elderly patients with potentially disabling outcomes and a marked impairment of quality of life. Taking into account their inherent instability, PFF are usually treated surgically within the shortest possible delay in order to reduce the risk of major and minor complications, the length of hospitalization and related costs. In this setting, most retrospective and prospective studies have reported a similar 30-day mortality rate comparing Spinal Anesthesia (SA) and General Anesthesia (GA), often recommending an adjuvant Peripheral Nerve Block (PNBs) to control postoperative pain. There is consensus that anticoagulant therapy, lack of pharmacological optimization or other conditions may represent a contraindication to SA. In these cases, blocking the nerves responsible for innervation of the proximal femur (i.e., the femoral, lateral femoral-cutaneous, obturators and sciatic nerves) may be a useful option. This study will aim to compare the incidence of intraoperative and postoperative adverse events, as well as the analgesic efficacy of the PNBs compared to SSA in patients diagnosed with PFF who underwent intramedullary nailing as a method of fixation.
Detailed description
A venous access (16-18 G) will be placed in the operating room and antibiotic prophylaxis will be administered (Cefazolin 1 or 2 gr. iv or, in case of allergy, Clindamycin 600 mg iv). Pantoprazole 40 mg iv will also be administered. Pulse oximetry (SpO2), heart rate (HR), body temperature (C°), continuous invasive blood pressure (cIBP), brain oximetry with ForeSight will be monitored. Risk factors of Postoperative Nausea and Vomiting (PONV) will be assessed using the Apfel score. Antiemetic prophylaxis will be administered in accordance with the 2020 Fourth Consensus Guidelines for the Management of PONV. A pre-loading will be started with 500 ml of crystalloids iv will be administered; pre-procedural sedation will be performed with Midazolam 0.03 mg/Kg until a Richmond Agitation Sedation Scale (RASS) -1 or -2 will be obtained. All patients will receive intraoperative sedation with Dexmedetomidine 0.7 gamma/Kg/h and o2-therapy with a nasal cannula with a flow rate of 2L/min. We will also proceed to an intraoperative fluid administration of 15-20 ml / kg / hour of iv crystalloids. Rate of hypotension and bradycardia will be monitored during surgery. At this point, the type of anesthesia will be followed based on the randomization group.The following variables will be evaluated:
- intraoperative haemodynamic adverse events (rates of hypotension and bradycardia)
- postoperative adverse events (rates of nausea/vomiting and delirium and rate of deep vein thrombosis, myocardial infarction and neurological lesion during the hospital stay);
- postoperative pain evaluated by NRS and PAINED
- time to mobilization
- need of analgesic rescue dose after surgery
- lenght of stay
- bromage and hollmen scale of healthy limb and fractured limb assessed at different time
- surgical satisfaction (evaluated with 6-point Likert scale).
- the duration of surgery (min)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective Spinal Anesthesia | Active comparator | Procedure: Selective Spinal Anesthesia, Drug: Anesthesiological mixtures (Spinal anesthesia)The participant will receive selective spinal anesthesia. |
| Peripheral nerve blocks | Active comparator | Procedure: Peripheral nerve blocks, Drug: Anesthesiological mixtures (Peripheral nerve block)The participant will receive a combination of femoral nerve block, sciatic nerve block with parasacral approach, lateral femoral cutaneous nerve block and obturator nerve block. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Selective Spinal AnesthesiaSelective Spinal Anesthesia will be performed at the L2-L3 or L3-L4 interspace with the patients lying in the lateral position (fractured side up). Anesthesiologists will determine the needling point for spinal anesthesia with reference to Tuffier's line, a virtual line connecting the tops of the iliac crests of a patient. A small dose of LA (4 ml of 1% lidocaine) will be injected into the skin and soft tissues at the planned site of spinal needle insertion. The correct path for spinal needle placement will be identified with the needle infiltration. The technique will be performed aseptically in the subarachnoid space after observing clear Cephalo-Spinal Fluid (CSF) in the spinal needle 25 Gauge, and without releasing the CSF. Selected patients will receive Hypobaric Bupivacaine 0.5% 7.5 mg and Sufentanil 5 µg and will maintain the lateral position for 15 min. At the end of these they will be gently placed in supine position. | Procedure or surgery | Selective Spinal Anesthesia |
| Peripheral nerve blocksIn this group, four nerve blocks will be associated to ensure adequate anesthesia and analgesia during surgery. Sciatic nerve blocks with para sacral approach will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the related muscles. Next, an anesthetic solution of Ropivacaine 0.375% (dose 37.5 mg) plus Mepivacaine 1% (dose 100 mg) and Dexamethasone 4mg, total volume 21 ml, will be injected. Lateral femoral cutaneous, femoral and obturator nerve blocks, femoral will be performed with the ultrasound technique. After identifying the nerves, a needle will be inserted with an "in plane" approach and will be injected. The anesthesia mixture will consist for all of :Ropivacaine 0.375% plus Mepivacaine 1% plus dexamethasone 4 mg. The volumes of the 3 anesthesia mixtures will be respectively: 1ml, 15ml,5ml. | Procedure or surgery | Peripheral nerve blocks |
| Anesthesiological mixtures (Spinal anesthesia)The anesthesia mixtures will be injected into the subarachnoid space for spinal anesthesia. It will consist of the following local anesthetics and adjuvants: Hypobaric Bupivacaine 0.5% 7.5 mg and Sufentanil 5 µg. | Drug | Selective Spinal Anesthesia |
| Anesthesiological mixtures (Peripheral nerve block)The anesthesia mixtures will be injected into selected peripheral nerves . It will consist of the following local anesthetics and adjuvants: Ropivacaine 0.375% plus Mepivacaine 1% and Dexamethasone 4 mg. | Drug | Peripheral nerve blocks |
Primary outcome
Postoperative pain evaluated by NRS scales
Time frame: Every 6 hours during treatment until the first 24 postoperative hours
NRS assessment will be carried out using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". patients will be asked to circle the number between 0 and 10 that fits best to their pain intensity.
Postoperative pain evaluated by PAINAD scales
Time frame: Every 6 hours during treatment until the first 24 postoperative hours
The PAINED scale (Pain Assessment in Advanced Dementia Scale) assesses 5 items: facial expression, breathing, negative vocalizations, consolability and body language with a range from 0 to 10 (1-3=mild pain; 4-6=moderate pain; 7-10=severe pain).
Rate of postoperative nausea and vomiting (PONV)
Time frame: Every 6 hours during treatment until the first 24 postoperative hours
We will analyze the risk factors of postoperative nausea and vomiting (PONV) by administering an Apfel score to each patient, practicing intraoperative and postoperative antiemetic treatment in accordance with the 2020 Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting.
Rate of Delirium
Time frame: Every 6 hours during treatment until the first 24 postoperative hours
Postoperative delirium (POD) is an acute and fluctuating alteration of mental state of reduced awareness and disturbance of attention, which begins in the recovery room and occurs up to 5 days after surgery. POD will be detected by "3-Minute Diagnostic Confusion Assessment Method" (3D-CAM) and has four features: (1) altered mental status/fluctuating course, (2) inattention, (3) altered level of consciousness, and (4) disorganized thinking [27]. For the prevention and treatment of POD, we will follow the 2017 European Society of Anesthesiology guidelines.
Rate of deep vein thrombosis
Time frame: up to 1 weeks
The diagnosis of Deep Vein Thrombosis will be based on postoperative observations of the affected limbs during the patient's hospital stay; the following manifestations will be monitored: limb swelling, pain, elevated skin temperature, changes in skin color, venous return disorders, Homans' sign, and Neuhof's sign. Color-Doppler ultrasound will be performed bilaterally, in case of positivity of clinical signs and symptoms.
Rate of myocardial infarction
Time frame: up to 1 weeks
The typical symptoms of myocardial ischemia, combined with characteristic changes on an ECG and a significant increase in blood levels of high-sensitivity cardiac troponins, will be used to diagnose a Myocardial Infarction. In cases where the diagnosis is uncertain, it will be necessary to conduct additional non-invasive evaluations, such as an echocardiogram
Rate of neurological lesion
Time frame: up to 1 weeks
Neurological lesion was evaluated based on the presence of sensory, motor, or both neurological symptoms
Intraoperative haemodynamic adverse events
Time frame: From the beginning to the end of surgery
Hypotension defined as a Systolic Blood Pressure (SBP) of less than 90 mm Hg for more than 5 minutes or a decrease of 35% in the Mean Arterial Pressure (MAP). Bradicardia, indicated by a heart rate of fewer than 60 beats per minute for more than 5 minutes.
4 secondary outcomes
Need of analgesic rescue dose
Time frame: From the end of treatment to 24 hours postoperatively
Time to mobilization (hours)
Time frame: Time to mobilization will be assessed immediately after the locoregional procedure, up to 24 hours postoperatively.
Lenght of stay (days)
Time frame: from date of hospital admission up to 1 weeks
Bromage and Hollmen scale of healthy limb and fractured limb assessed at different time
Time frame: Motor block and sensory block were assessed before LA injection (baseline time) and 10 , 15 and 20 minutes after baseline time and every 30 minute during the surgery
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 4 May 2025.
- Derived from this study: PubMed 41340155Coviello A, Cirillo D, Bernasconi A, de Siena AU, Spasari E, Barone MS, Piccione I, Ranieri G, Tognu A, Servillo G, Iacovazzo C. Peripheral nerve blocks vs selective spinal anesthesia in patients with femur fracture: a patient-, surgeon-, and assessor-blinded randomized controlled study. J Anesth Analg Crit Care. 2025 Dec 3;5(1):88. doi: 10.1186/s44158-025-00302-6.
- Individual participant dataSharing planned: Undecided
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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.
Antonio Coviello, Researcher principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Spinal Anesthesia, Peripheral nerve blocks and Anesthesiological mixtures (Spinal anesthesia) in people with Femur Fracture and Peripheral Nerve Block, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 May 2025. 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 Italy. 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?
Postoperative pain evaluated by NRS scales (time frame: Every 6 hours during treatment until the first 24 postoperative hours). The study lists 8 primary outcomes in all. 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 NCT06155903, which also lists 1 linked publication.
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 4 May 2025.