Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- recovery time from motor blockade
研究概览
简要总结
The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery. Onset and recovery times of sensory and motor blockade will be compared.
详细描述
The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery.
Faster onset and shorter elimination time favours a short-acting local anaesthetic for spinal anesthesia for out-patient lower limb surgery, e.g. knee arthroscopy, foot and varices surgery. Patients will recover faster and less complications will be expected.
Articaine is said to act faster and shorter than a low dose of bupivacaine. There are not enough data available to establish that articaine is as safe as and more effective by outpatient lower limb surgery than bupivacaine.
Spinal anesthesia with articaine will be compared to spinal anesthesia with bupivacaine in a randomized double blind clinical trial.
Endpoints are:
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years
- •Patients planned for an outpatient lower limb surgery
- •Procedure under spinal anesthesia
- •Informed consent
排除标准
- •Contra-indications spinal anesthesia
- •History of allergic reactions on amide-type local anesthetics
- •Length < 1.60 m or > 1.90 m
- •BMI < 18.5 kg/m2 or > 35 kg/m2
- •Pregnancy
结局指标
主要结局
recovery time from motor blockade
次要结局
- onset of sensory and motor blockade
- maximum spread of sensory blockade (30 min after spinal injection of anesthetic)
- spread of sensory blockade after 1,5 hour
- recovery time from sensory blockade
- time to micturation
- complications