Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture

NCT06155903 | Completed DMC

• 1 other identifier: 2-2023-533
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Femur Fracture; Peripheral Nerve Block; Spinal Anesthesia

Keywords

SPINAL ANESTHESIA; FEMUR FRACTURE; NERVE BLOCK; LOCOREGIONAL ANESTHESIA

Outcome Measures

Primary Outcomes (8)

• 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.

  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).

  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.

  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.

  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.

  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

  up to 1 weeks

• Rate of neurological lesion

  Neurological lesion was evaluated based on the presence of sensory, motor, or both neurological symptoms

  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.

  From the beginning to the end of surgery

Secondary Outcomes (4)

• Need of analgesic rescue dose

  From the end of treatment to 24 hours postoperatively

• Time to mobilization (hours)

  Time to mobilization will be assessed immediately after the locoregional procedure, up to 24 hours postoperatively.

• Lenght of stay (days)

  from date of hospital admission up to 1 weeks

• Bromage and Hollmen scale of healthy limb and fractured limb assessed at different time

  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

Other Outcomes (2)

• The duration of surgery (min)

  From the beginning of surgery up to 120 minutes

• Surgical satisfaction related to anesthesiological plane

  1 hours after surgery

Study Arms (2)

Selective Spinal Anesthesia

ACTIVE COMPARATOR

The participant will receive selective spinal anesthesia.

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.

Procedure: Peripheral nerve blocks; Drug: Anesthesiological mixtures (Peripheral nerve block)

Interventions

Selective Spinal Anesthesia PROCEDURE

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.

Selective Spinal Anesthesia

Peripheral nerve blocks PROCEDURE

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.

Peripheral nerve blocks

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.

Selective Spinal Anesthesia

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.

Peripheral nerve blocks

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, Naples, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 41340155 DERIVED

MeSH Terms

Conditions

Femoral Fractures

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Antonio Coviello, Researcher

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The triple-blind approach (operating room anesthetist, surgeon, and patient) will be implemented as follows: a team will prepare the anesthetic mixtures in a dedicated room, isolated from the operating room and the Post-Anesthesia Care Unit (PACU) where a different team will be then responsible for the intra and postoperative management. The surgery will be conducted by the surgeon and the surgical team without knowledge of the anesthesiology procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: December 5, 2023
• Study Start: December 31, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 15, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-05

Locations

IT (1)