NCT02561468已完成不适用
The Preemptive Analgesic Efficacy of Nefopam
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The change of pain numerical rating score from postoperative 30 min until postoperative 3 month
研究概览
简要总结
Nefopam is administered as a preemptive analgesic drug to the patient undergoing breast cancer surgery. It will be evaluated whether postoperative acute and chronic pain can be reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with breast cancer
- •Lumpectomy with axillary lymph node dissection or Lumpectomy with sentinel lymph node biopsy
- •American Society of Anesthesiologists physical status I or II
排除标准
- •Cardiac disease
- •Monoamine oxidase inhibitor user
- •Urologic disease
- •Preoperative analgesic drug medication
- •Pregnancy
- •Recurred breast cancer patient
研究组 & 干预措施
Nefopam
Experimental
20 mg nefopam in 100 ml normal saline is infused before starting operation.
干预措施: Nefopam (Drug)
Control
Placebo Comparator
100 ml normal saline is infused before starting operation.
干预措施: Saline (Drug)
结局指标
主要结局
The change of pain numerical rating score from postoperative 30 min until postoperative 3 month
时间窗: Postoperative 30 min, postoperative 1 day, postoperative 1 week, postoperative 3 month
次要结局
- The dose of ketorolac administered to the patient.(postoperative 1 day)
研究者
Hyo-Seok Na
Dr
Seoul National University Bundang Hospital
研究点 (1)
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