NCT02949310Unknown不适用
Effectiveness of Nefopam in Breast Cancer Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change of cumulative analgesia volume infused via intravenous patient-controlled analgesia device
研究概览
简要总结
Breast cancer surgery is known to cause severe acute postoperative pain, which can persist for a long time. The investigators administered nefopam preventively to patients undergoing total mastectomy or modified radical mastectomy with axillary lymph node dissection or sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Total mastectomy
- •Modified radical mastectomy
- •Nipple-sparing mastectomy
- •American Society of Anesthesiologists physical status I or II
- •Postoperative use of intravenous patient-controlled analgesia
排除标准
- •Chronic analgesia medication
- •Pregnancy
- •Lactating women
- •Previous operation history due to breast cancer
- •Cooperation with other surgery
- •Contraindication of nefopam
研究组 & 干预措施
Control
Placebo Comparator
Placebo use instead of nefopam
干预措施: Normal Saline (Drug)
Nefopam
Experimental
Intraoperative use of nefopam 40 mg
干预措施: Nefopam (Drug)
结局指标
主要结局
Change of cumulative analgesia volume infused via intravenous patient-controlled analgesia device
时间窗: At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month
次要结局
- Change of numerical rating scale for postoperative pain(At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month)
研究者
Hyo-Seok Na
Clinical professor
Seoul National University Bundang Hospital
研究点 (1)
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