Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery: A Double Blind Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Onset time (sec) of sensory and motor blockade (after administration of drug)
研究概览
简要总结
The purpose of this study is to compare two short-acting local anesthetics, articaine and lidocaine, for spinal anesthesia in day-case surgery. The onset time of the sensory- and motor block, recovery time until discharge and complications will be studied.
详细描述
The ideal spinal anesthesia in day-case surgery is characterized by a short onset of sensory and motor blockade, and a rapid recovery after the operation. Short-acting local-anesthetics are used frequently in this setting.
Lidocaine is one of the agents that is used most frequently. It has been associated with an increased incidence of Transient Neurological Symptoms (TNS). Articaine is another agent that is being used more often and is said to act faster and shorter than lidocaine.
We will compare spinal anesthesia with lidocaine and articaine in a randomized double-blind clinical trial. Endpoint are:
- onset of sensory and motor block
- recovery from sensory and motor block
- time to micturition
- patient satisfaction
- complications
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •ASA I-III
- •Patients planned for a short surgical procedure on lower extremities or lower abdomen.
- •Procedure in day-case setting
- •Procedure under spinal anesthesia
- •Informed consent
排除标准
- •Contra-indications spinal anesthesia
- •History of allergic reactions on amide-type local anesthetics
- •Pregnancy
研究组 & 干预措施
lidocaine
干预措施: spinal administration of lidocaine (Drug)
articaine
干预措施: spinal administration of articaine (Drug)
结局指标
主要结局
Onset time (sec) of sensory and motor blockade (after administration of drug)
Spread of sensory blockade (30 min after administration of drug, dermatomal level)
Recovery time (min) from sensory and motor blockade
次要结局
- Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy)
- Complications
- Patient satisfaction