NCT01245868已完成4 期
Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine?
Frederikssunds Hospital, Denmark2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Duration of spinal blockade
研究概览
简要总结
The purpose of the study is to investigate if a small amount of lignocaine added to bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can shorten the duration of the sensoric and the motoric blockade.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient want spinal anaesthesia
- •No contradictions against spinal anaesthesia
- •Healthy people (ASA-score 1 or 2)
- •Body mass index < 35 and between 155 and 190 cm
排除标准
- •Known allergic reactions to planned drugs
- •Neurologic disturbances
研究组 & 干预措施
Bupivacaine
Experimental
Bupivacaine as used routinely
干预措施: bupivacaine (Drug)
Lidocaine added to bupivacaine
Placebo Comparator
lidocaine is added to bupivacaine
干预措施: Lidocaine (Drug)
Lidocaine added to bupivacaine
Placebo Comparator
lidocaine is added to bupivacaine
干预措施: bupivacaine (Drug)
结局指标
主要结局
Duration of spinal blockade
时间窗: Repeating monitoring every 15 minutes after applying the blockade, up to 360 minutes.
次要结局
- Time to fulfillment of discharge criteria from the hospital.(Evaluated every 15 minutes after the operation up to 360 minutes. On average 200 to 300 minutes.)
研究者
Jon Jacobsen
Chief consultant
Frederikssunds Hospital, Denmark
研究点 (2)
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