The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine for Spinal Anesthesia in Total Knee Replacement Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- the sensory level of spinal anesthesia, the quality of intraoperative analgesia
研究概览
简要总结
Intrathecal epinephrine has been known to increase the duration of spinal anesthesia, or increase the quality of anesthesia. However, there is still a controversy, and the mechanism of epinephrine is recently suggested as a modulator of pain information in the spinal cord. Therefore, the investigators try to investigate the dose sparing effect of intrathecal epinephrine for spinal anesthesia with bupivacaine.
详细描述
For patient undergoing total knee replacement arthroplasty, patients injected intrathecally with bupivacaine 8 mg were compared with those with bupivacaine 8 mg with 25 mcg of epinephrine, bupivacaine 8 mg with 50 mcg of epinephrine, and those with bupivacaine 8 mg with 100 mcg of epinephrine. The investigators compared the characteristics of spinal anesthesia including the quality and complication of spinal anesthesia. The researchers investigated whether intrathecal dose of epinephrine can reduce bupivacaine requirement and this effect is dependent on the dose of epinephrine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient undergoing total knee replacement arthroplasty
排除标准
- •patient with cardiac or pulmonary disease (ASA class III or more)
- •patient undergone previous spine surgery
- •patient undergoing revised knee replacement
研究组 & 干预措施
Placebo
8 mg bupivacaine only
干预措施: Placebo (Drug)
Epi 25
8 mg of bupivacaine mixed with 25 mcg of epinephrine
干预措施: epinephrine 25 (Drug)
Epi 50
8 mg of bupivacaine mixed with 50 mcg of epinephrine
干预措施: Epinephrine 50 (Drug)
Epi 100
8 mg of bupivacaine mixed with 0.1 mg of epinephrine
干预措施: epinephrine 100 (Drug)
Epi 200
intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
干预措施: Epi 200 (Drug)
结局指标
主要结局
the sensory level of spinal anesthesia, the quality of intraoperative analgesia
时间窗: every 15 minutes
at 2, 5, 10, 20, and 30 min after the spinal injection and every 15 minutes thereafter until complete regression of spinal anesthesia.
次要结局
未报告次要终点