NCT06174363招募中不适用
Analgesic Efficacy of Maxigesic Added to Opioid Based-PCA in Patients Undergoing Breast Cancer Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Analgesic effect of Maxigesic
研究概览
简要总结
The present study aims to find a perioperative analgesic method that provides sufficient analgesia while reducing immune compromise in cancer surgery. This study is to investigate the analgesic effect and safety of Maxigesic inj. (a combination of acetaminophen 1000 mg and ibuprofen 300 mg), which is added to opioid-based IV-PCA in patients undergoing breast cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient aged 20 to 70 years with ASA classification 1 to 3 undergoing breast cancer surgery (cancer resection or reconstruction)
排除标准
- •ASA classification 4/ allergy to acetaminophen, NSAIDs, opioid/ severe liver or renal dysfunction/ pregnancy
研究组 & 干预措施
Study group
Placebo Comparator
Group administered Maxigesic solution
干预措施: Maxigesic (Drug)
Control group
Experimental
Group administerd 0.9% saline solution
干预措施: 0.9% saline solution (Drug)
结局指标
主要结局
Analgesic effect of Maxigesic
时间窗: postoperative 30 minutes/ 6 hours/ 24 hours/ 48 hours
Postoperative pain intensity is assessed with NRS: numerical rating scales (0 = no pain ∼ 10 = worst pain).
次要结局
- Incidence of Adverse reactions (Safety)(postoperative 30 minutes/ 6 hours/ 24 hours/ 48 hours)
研究者
研究点 (1)
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