NCT03051503Unknown4 期
Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
South Egypt Cancer Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total dose of morphine consumption in the first 48 hours postoperative
研究概览
简要总结
to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I - II patients
- •aged 30-60 years
- •body weight ranged between 65-10kg
排除标准
- •Patients with history of allergy to morphine
- •chronic intake of analgesics or non-steroidal anti-inflammatory drug 24 h prior to surgery,
- •there was a history of a psychiatric disorder patients weight was less then 50kg.
- •impaired kidney function.
研究组 & 干预措施
The Transdermal Therapeutic System-Fentanyl (TTS-F) group
Active Comparator
(TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively.
干预措施: The Transdermal Therapeutic System-Fentanyl (TTS-F) (Drug)
Intravenous patient-controlled analgesia (PCA) morphine
Placebo Comparator
IV (PCA) morphine for pain in the postoperative period.
干预措施: Intravenous patient-controlled analgesia (PCA) morphine (Device)
结局指标
主要结局
Total dose of morphine consumption in the first 48 hours postoperative
时间窗: 48 hours
Total dose of I.V. PCA morphine consumption in the first 48 hours postoperative
Visual Analogue Scale
时间窗: 48 hours
Pain measurement scale
次要结局
- Level of stress hormones(48 hours)
- Side effects related to the opioids(48 hours)
研究者
Dr.mohamad farouk mohamad
lecturer of anesthesia and pain relief
South Egypt Cancer Institute
研究点 (1)
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