Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture: A Prospective Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Selective Spinal Anesthesia
- Conditions
- Femur Fracture
- Sponsor
- Federico II University
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Postoperative pain evaluated by NRS scales
- Status
- Completed
- Last Updated
- 12 months ago
Overview
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.
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)
Investigators
Antonio Coviello
Researcher
Federico II University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Selective Spinal Anesthesia
The participant will receive selective spinal anesthesia.
Intervention: Selective Spinal Anesthesia
Selective Spinal Anesthesia
The participant will receive selective spinal anesthesia.
Intervention: Anesthesiological mixtures (Spinal anesthesia)
Peripheral nerve blocks
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.
Intervention: Peripheral nerve blocks
Peripheral nerve blocks
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.
Intervention: Anesthesiological mixtures (Peripheral nerve block)
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- 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)