Duloxetine for Post Operative Analgesia After Modified Radical Mastectomy:A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
The aim of this study is to evaluate the role of duloxetine in controlling pain after radical mastectomy.
详细描述
Inadequate control of postoperative pain is associated with increased length of hospital stay, increased hospital cost, sleep disturbance, depression, functional impairment and affects the quality of life.
Modified is one of the commonly performed procedures which is associated with severe postoperative pain.
Preemptive analgesia is the analgesic treatment initiated before the surgical procedure to prevent central sensitization from the noxious stimuli. Drugs such as gabapentin, pregabalin, serotonin-norepinephrine reuptake inhibitors, dexamethasone, and cyclooxygenase-2 inhibitors have been used for preemptive analgesia.
There are contrary results about the role of duloxetine in mangement of acute postoperative pain.
Arecent meta-analysis was done in 2020 that concluded that the currently available evidence does not support the clinical use of duloxetine for the management of acute postoperative pain,so we will discuss that in this study.
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
- None
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
- •Adult female patients aged (18 - 60) years undergoing modified radical mastectomy. American Society of Anesthesiologists Classification I-II-III
排除标准
- •Known Allergies to duloxetine.
- •Abnormal liver or renal function tests.
- •Narrow angle glaucoma.
- •Being a chronic opioid abuser (more than 3 months)
- •Being on chronic gabapentin or pregabalin (more than 3 months)
- •Being on Monoamine oxidase inhibitor, tricyclic antidepressant, or fluvoxamine.
- •Pregnant female
- •Patients with psychiatric disorders or seizure disorders.
结局指标
主要结局
Total morphine consumption
时间窗: 48 hours postoperatively
Postoperative Total morphine consumption will be recorded
次要结局
- First analgesic request(24 hours postoperatively)
- Post-operative pain(48 hours postoperatively.)
- Mean arterial blood pressure(48 hours postoperatively)
- Heart rate(48 hours postoperatively)
- Adverse effects(48 hours postoperatively)
研究者
Dina Abdel monem Elfeky
Principal investigator
Tanta University