NCT01261897已完成4 期
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain during 45 degrees active flexion of the knee
研究概览
简要总结
The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total Knee Arthroplasty in general anaesthesia
- •BMI 18-40
- •Written informed consent
排除标准
- •Can not cooperate to the exam
- •Do not speak or understand Danish
- •Drug allergy
- •Alcohol or drug abuse
- •Daily consumption of strong opioids
研究组 & 干预措施
Adductor-Canal-Blockade with Ropivacaine
Active Comparator
干预措施: Adductor-Canal-Blockade with Ropivacaine (Procedure)
Adductor-Canal-blockade with saline
Placebo Comparator
干预措施: Adductor-Canal-blockade with saline (Procedure)
结局指标
主要结局
Pain during 45 degrees active flexion of the knee
时间窗: 1 hour postoperative
0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative
次要结局
- Pain during 45 degrees active flexion of the knee(0-6 hours postoperative)
- Pain during rest(1-6 hours postoperative)
- A change in pain score in the ropivacaine group, after activating the block(30-60 minutes postoperative)
- Total morphine consumption(30 minutes - 6 hours postoperative)
- Postoperative nausea(1-6 hours postoperative)
- Postoperative vomiting(1-6 hours postoperative)
- Zofran consumption(1-6 hours postoperative)
- Sedation(1-6 hours postoperative)
研究者
Pia Jaeger
MD
Rigshospitalet, Denmark
研究点 (1)
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