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

NACompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

December 31, 2023

Primary Completion Date

April 1, 2024

Study Completion Date

June 15, 2024

Conditions
Femur FracturePeripheral Nerve BlockSpinal Anesthesia
Interventions
PROCEDURE

Selective Spinal Anesthesia

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.

PROCEDURE

Peripheral nerve blocks

"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."

DRUG

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

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.

Trial Locations (1)

80131

University of Naples Federico II, Naples

All Listed Sponsors
lead

Federico II University

OTHER

NCT06155903 - Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture | Biotech Hunter | Biotech Hunter