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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
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.
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.
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.
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.
University of Naples Federico II
Naples, Naples, Italy
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: up to 1 weeks
Rate of neurological lesion
Neurological lesion was evaluated based on the presence of sensory, motor, or both neurological symptoms
Time frame: 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.
Time frame: From the beginning to the end of surgery
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.
Time frame: 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).
Time frame: 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.
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
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.
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
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