Continuous Femoral Block With Levobupivacaine 0.125% or Ropivacaine 0.2% in Elderly Patients With Femoral Fractures

Study Overview
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Brief Summary
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This study evaluates the continuous femoral block between levobupivacaine 0.125% and ropivacaine 0.2% in patients with proximal femoral fracture.These patients will be divided into 2 groups of 35 patients, one L group (levobupivacaine 0.125%) and one R group (ropivacaine 0.2%) distributed randomly, receiving continuous infusion through patient controlled analgesia (PCA) pump with the following parameters: infusion 5 ml / h, bolus 5 ml, lockout 30 min.

Detailed Description
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Pain is associated with neurohormonal stress, myocardial ischemia and delayed mobilization, thus being able to increase the hospitalization time and associated with increased postoperative mortality. Regional anesthesia through simple or continuous femoral nerve block are options for analgesia in patients with femoral fracture, as well as analgesia by venous opioids. A potential benefit of regional anesthesia is precisely to avoid the use of opioids and other general anesthetics, which in turn are also closely related to postoperative delirium. Continuous femoral block, since the preoperative period, is associated with the reduction of acute pain and opioid consumption, in patients with femoral neck fractures. There are few studies available in the literature comparing analgesic equipotency between levobupivacaine and ropivacaine in peripheral nerve blocks. In none of them, the peripheral analgesia in the femoral nerve, for proximal femoral fracture was compared.

Official Title
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Comparison Between Continuous Femoral Block With Levobupivacaine 0.125% and Ropivacaine 0.2% for Preoperative Analgesia, in Patients Over 70 Years Old, With Proximal Femoral Fractures: a Randomized, Double-blind Study

Conditions
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Femur Fracture, Hip Fractures

Intervention / Treatment
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* Procedure: continuous femoral block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 70 years old or more patients with femur fracture physical status risk American Society of Anesthesiologists (ASA) P1 - P3 Exclusion Criteria: physical status ASA P4 patients with BMI > 35 systemic infection Injury or infection at the site of installation of the femoral perineural catheter Catheter displacement of the perineural site Montreal Cognitive Assessment (MoCA) < 26 Patients operated before 24 hours of hospital admission

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: levobupivacaine 0.125%<br>continuous femoral block with levobupivacaine 0.125%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes | Procedure: continuous femoral block<br>* infusion of anesthetic by PCA pump<br>|
| Active Comparator: ropivacaine 0.2%<br>continuous femoral block with ropivacaine 0.2%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes | Procedure: continuous femoral block<br>* infusion of anesthetic by PCA pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensity of individual pain episodes | Self report pain intensity in the preoperative period. Scored 0-10 (0 = no pain; 10 = pain as bad as can be) | 6 hours after hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of PCA firing | in each patient at time of evaluation of pain | 72 hours | 
| Degree of satisfaction with analgesic therapy | using the 5-point rating scale (very dissatisfied, dissatisfied, neutral, satisfied or very pleased) | up to 72 hours - at the moment of surgery; or at the end of 72 hours | 
| Quality of sleep | very good, good, bad and very bad | up to 72 hours | 
| the cost of analgesic therapy | including catheters, PCA and medication in each patient | up to 72 hours | 
| adverse event | paresthesia, nausea, vomiting, ringing in the ear, metallic taste, convulsion or cardiac arrest | up to 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, continuous, femoral block