Continuous Femoral Block With Levobupivacaine 0.125% or Ropivacaine 0.2% in Elderly Patients With Femoral Fractures
- Conditions
- Hip FracturesFemur Fracture
- Interventions
- Procedure: continuous femoral block
- Registration Number
- NCT03815565
- Lead Sponsor
- Hospital Municipal Miguel Couto
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 70 years old or more
- patients with femur fracture
- physical status risk American Society of Anesthesiologists (ASA) P1 - P3
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ropivacaine 0.2% continuous femoral block continuous femoral block with ropivacaine 0.2%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes levobupivacaine 0.125% continuous femoral block continuous femoral block with levobupivacaine 0.125%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes
- Primary Outcome Measures
Name Time Method intensity of individual pain episodes 6 hours after hospital admission Self report pain intensity in the preoperative period. Scored 0-10 (0 = no pain; 10 = pain as bad as can be)
- Secondary Outcome Measures
Name Time Method Degree of satisfaction with analgesic therapy up to 72 hours - at the moment of surgery; or at the end of 72 hours using the 5-point rating scale (very dissatisfied, dissatisfied, neutral, satisfied or very pleased)
the cost of analgesic therapy up to 72 hours including catheters, PCA and medication in each patient
adverse event up to 72 hours paresthesia, nausea, vomiting, ringing in the ear, metallic taste, convulsion or cardiac arrest
Number of PCA firing 72 hours in each patient at time of evaluation of pain
Quality of sleep up to 72 hours very good, good, bad and very bad
Trial Locations
- Locations (1)
Rafael M Linhares
🇧🇷Rio de Janeiro, Brazil