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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- intensity of individual pain episodes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Only the pharmacist chief knows which participant belongs to each arm
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •70 years old or more
- •patients with femur fracture
- •physical status risk American Society of Anesthesiologists (ASA) P1 - P3
排除标准
- •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
结局指标
主要结局
intensity of individual pain episodes
时间窗: 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)
次要结局
- Degree of satisfaction with analgesic therapy(up to 72 hours - at the moment of surgery; or at the end of 72 hours)
- the cost of analgesic therapy(up to 72 hours)
- adverse event(up to 72 hours)
- Number of PCA firing(72 hours)
- Quality of sleep(up to 72 hours)
研究者
Rafael Mercante Linhares
Head of Anesthesiology and Pain Medicine Department
Hospital Municipal Miguel Couto