NCT02962024已完成不适用
Does Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block for Post Mastectomy Pain Has a System Analgesic Effect? A Clinical and Pharmacokinetics Study
Fatma Adel El sherif,MD1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年11月最近更新:
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
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- serum morphine level after local injection
研究概览
简要总结
the investigators aim is to investigate and explore the effect 10 mg morphine added to local anesthetics in serratus anterior plane block for post mastectomy pain management after modified radical mastectomy in patients with breast cancer with assessment of its serum level if it will be absorbed systemically or not?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
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
- •(ASA) class I-II
- •body weight of 50 - 90 kg
排除标准
- •a history of bleeding diathesis,
- •relevant drug allergy, opioid dependence,
- •sepsis, prior surgery in the supraclavicular, infraclavicular or axillary regions, alcohol or drug abuse , patients with advanced cardiovascular disease
研究组 & 干预措施
morphine sulphate
Active Comparator
10mg locally morphine hydrochloride once betwwen serratus muscle and latissmus dorsi muscle
干预措施: Morphine Sulfate (Drug)
bupivacaine hydrochloride
Placebo Comparator
0.25%locally bupivacaine hydrochloride once
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
serum morphine level after local injection
时间窗: 24 hours
concentration of serum morphine in ng/ml after local injection
次要结局
未报告次要终点
研究者
Fatma Adel El sherif,MD
lecturer of anesthesia, ICU and pain management
Assiut University
研究点 (1)
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