Clinical trial

Peripheral Nerve Block vs Spinal Anesthesia in Patients With Femur Fracture: A Prospective Randomized Controlled Study

Name

2-2023-533

Description

Femur Fractures (PF) are nowadays one of the main social and health problems in industrialized countries. PF are defined as crack or break of the proximal femur and they represent an important cause of morbidity and mortality in elderly population. The main prospective and retrospective studies do not show the superiority of subarachnoid anesthesia over general anesthesia in terms of 30-day mortality and post-operative complications, however they always recommend the execution of PeripheralNerve Blocks (PNB). Loco-regional anesthesia plays a fundamental role in the treatment of peri-operative pain assuring better hemodynamic stability and has already fully entered national and international pain management protocols, because it allows faster recovery times with a reduction in the use of intravenous analgesic drugs in particular opioids and consequently a faster discharge and a reduction in peri-operative complications and the costs of assistance. The aim of our study will be to propose an anesthetic approach based on PNB that could be particularly suitable for frail patients especially when Neuroaxial Anesthesia (NA) is not feasible due to difficulty to position the patient or to the withdrawal time of anticoagulant or antiplatelet therapies.

Trial arms

Trial start

2023-07-01

Estimated PCD

2024-04-01

Trial end

2024-06-15

Status

Active (not recruiting)

Treatment

Spinal anesthesia

Spinal anesthesia will be performed at the L2-L3 or L3-L4 interspace with the patients in the lateral position with the fractured side up. A small dose of local anesthetic will be injected into the skin at the planned site of insertion. More local anesthetic will be then administered along the intended path of the spinal needle insertion to the estimated depth of the supraspinous ligament. This serves a dual purpose: additional anesthesia for the spinal needle insertion and identification of the correct path for spinal needle placement. 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 be received Hypobaric Bupivacaine 0.5% 10 mg and Sufentanil 5 µg and will be maintained the lateral position for 15 min. At the end of these they will be gently placed in supine position.

Arms:

Spinal Anesthesia

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% (dose 9.375 mg) plus Mepivacaine 1% (dose 25 mg). The volumes of the 3 anesthesia mixtures will be respectively: 1ml, 15ml,5ml.

Arms:

Peripheral nerve block

Anesthesiological mixtures (Spinal anesthesia)

The anesthesia mixtures were injected into the subarachnoid space for spinal anesthesia. It consisted of the following local anesthetics and adjuvants: Hypobaric Bupivacaine 0.5% 10 mg and Sufentanil 5 µg.

Arms:

Spinal Anesthesia

Anesthesiological mixtures (Peripheral nerve block)

The anesthesia mixtures were injected into selected peripheral nerves . It consisted of the following local anesthetics and adjuvants: Ropivacaine 0.375% plus Mepivacaine 1% and Dexamethasone 4 mg.

Arms:

Peripheral nerve block

Size

Primary endpoint

Postoperative pain evaluated by VAS scales

Every 6 hours during treatment until the first 24 postoperative hours

Postoperative pain evaluated by PAINAD scales

Every 6 hours during treatment until the first 24 postoperative hours

Eligibility criteria

"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 hoursPatients undergoing total hip arthroplasty "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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Blind: Quadruple (participant, surgeon, investigator, outcome assessor)', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 78, 'type': 'ACTUAL'}}

Updated at

2024-06-03

1 organization

Organization

Federico II University