The Effect of Peri-operative Mirtazapine on Acute and Chronic Post Mastectomy Pain (Prospective Randomized Controlled Study)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The cumulative postoperative 24 h morphine consumption
研究概览
简要总结
Our aim in this study will be to investigate the effect of mirtazapine on acute post-mastectomy pain manifested by total morphine consumption in first 24 hours and VAS score at rest and movement (primary outcomes). chronic neuropathic pain using LANSS Pain Scale (Leeds Assessment of Neuropathic Signs and Symptoms) and to evaluate the quality of recovery using the quality of recovery-40scoring system(QoR-40) (secondary outcomes) following modified radical mastectomy for breast cancer.
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
- Double (Participant, Care Provider)
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
- •female patients aged 20-70 years scheduled for modified radical mastectomy with axillary dissection for breast carcinoma
排除标准
- •known allergy to the study drugs significant organ dysfunction drug or alcohol abuse epilepsy patients with chronic pain or regularly receiving analgesics any psychiatric illness that would interfere with the perception and the assessment of pain
研究组 & 干预措施
Mirtazapine group
patients will receive orally the night before surgery the study medication and daily up to two weeks after: Mirtazapine group: Mirtazapine 30 mg tablet
干预措施: Mirtazapine 30 MG (Drug)
placebo group
patients will receive orally the night before surgery the study medication and daily up to two weeks after:
placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
The cumulative postoperative 24 h morphine consumption
时间窗: 24 hours
次要结局
- The visual analogue score of pain intensity(24 hours)
- The quality of recovery-40 questionnaire(24 hours)
- Assessment of sedation level(24 hours)
- Assessment of chronic pain(6 months)
- Depression score(6 months)
研究者
Ali Rabiee Ali
assistant lecturer
Assiut University