Randomized and Controlled Phase IV Clinical Trial on the Analgesic Effectiveness of the Combined Blockade in the Hip Fractures of the Elderly: Comparative Study Between Levobupivacaine and Ropivacaine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery
研究概览
简要总结
Prospective, low-level, non-commercial intervention, comparative clinical trial (phase IV) of balanced, randomized groups, to compare the analgesic efficacy of the local anesthetics Ropivacaine and Levobupivacaine in peripheral nerve block in hip fracture surgery in the elderly .
详细描述
There are several studies that try to identify the ideal anesthetic for the management and control of pain in hip fracture surgery in the elderly. The optimum would be to use an anesthetic with the lowest possible latency, since this will favor the start of surgery. And, at the same time, with a more lasting analgesia with the least motor impairment. Therefore, it is essential to collect data on efficacy (effective block that allows us to mobilize the patient), latency, and analgesic scales appropriate to the cognitive state of the study sample.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient will have to voluntarily sign and understand the informed consent that will be provided in writing.
- •Patients over 65 years of age, with a hip fracture, who are going to be operated on at the Salamanca University Assistance Complex (CAUSA).
排除标准
- •Rejection of the technique.
- •Allergy to any of the drugs.
- •Coagulation disorders.
- •Local infections instead of puncture.
- •Vascular prostheses at the femoral level.
研究组 & 干预措施
LEVOBUPIVACAINE
Patients treated with Levobupivacaine Altan 7.5 mg / ml solution for injection and infusion
干预措施: Levobupivacaine (Drug)
ROPIVACAINE
Patients treated with Ropivacaine Altan 2 mg / ml solution for infusion
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Evaluation of the Analgesic Efficacy of Both Local Anesthetics in the Regional Block of Hip Fracture Surgery
时间窗: 6h, 12h, 24h and 48h
The primary measure of efficacy in this study will be the difference in block duration. To evaluate this, the need for rescue medication will be assessed at several time points, including 6, 12, 24, and 48 hours.
次要结局
- Usefulness of the Chosen Analgesic Scale in Our Population, Especially in Patients With Cognitive Impairment.(The duration of treatment for each patient will be considered until the evaluation of the analgesic scale corresponding to 48 hours after the procedure is performed.)
- Secondary Effects Derived From the Combined Technique Described.(The duration of treatment for each patient will be considered until the evaluation of the analgesic scale corresponding to 48 hours after the procedure is performed.)
- Latency of Initiation.(The duration of treatment for each patient will be considered until the evaluation of the analgesic scale corresponding to 48 hours after the procedure is performed.)