NCT03165149已完成2 期
Effect of a Topical Ketamine on Acute and Chronic Post-mastectomy Pain, Dose Finding - Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the total amount of morphine consumption
研究概览
简要总结
The aim of this study is to investigate the effect of addition of different doses of Ketamine locally in acute and chronic post-mastectomy pain after breast cancer surgery and on the probability of developing chronic post-mastectomy pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American society of heart association class I-II female patients
- •aged 18-60 years
- •scheduled for modified radical mastectomy with axillary dissection for breast carcinoma
排除标准
- •known allergy to the study drugs
- •significant cardiac-
- •respiratory-
- •renal or hepatic disease
研究组 & 干预措施
Group (A)
Active Comparator
patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % )
干预措施: group (A) (Drug)
Group (B)
Active Comparator
patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) a
干预措施: group (B) (Drug)
Group (C)
Active Comparator
patients will receive 3 mg / kg of Ketamine diluted by 20 ml saline (0.9 %)
干预措施: group (c) (Drug)
结局指标
主要结局
the total amount of morphine consumption
时间窗: 48 hours
total amount of rescue analgesia
次要结局
- pain intensity(48 hours)
研究者
Fatma Adel El sherif,MD
lecturer of anesthesia, ICU and pain releif
Assiut University
研究点 (1)
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