Pain Relieving Potentials of Preoperative Combination of Single Dose Oral Duloxetine and Intravenous Magnesium Sulphate in Acute and Chronic Post Mastectomy Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time to first analgesic request
研究概览
简要总结
This study aims to evaluate the effect of combined duloxetine and IV Magnesium sulphate to decrease acute and chronic post mastectomy pain.
The study will be conducted in National Cancer Institute and all the participants will be enrolled from female patients scheduled for modified radical mastectomy under general anesthesia in National Cancer Institute, Cairo University.
详细描述
It has been reported recently that Duloxetine improved the quality of recovery in patients subjected to hysterectomy. In this context, mastectomy has a negative consequence starting from cancer diagnosis to the squeal of cancer-related treatments and it has been estimated that 20%-30% of patients with breast cancer suffer from depression and anxiety. Magnesium also antagonizes the release of inflammatory mediators such as histamine, serotonin, and cytokines in peripheral tissues.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years old.
- •American Society of Anesthesiologists (ASA) physical I-II
- •Scheduled for modified radical mastectomy (MRM) under general anesthesia.
排除标准
- •Liver or kidney disease
- •Patient with previous chronic pain on opioids
- •Patients on antidepressants and antipsychotics.
- •Allergies to study drugs
研究组 & 干预措施
DM group
Patients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline.
干预措施: Magnesium sulphate and Duloxetine (Drug)
D group
Patients received Duloxetine 30mg orally and 200 ml of normal saline.
干预措施: Duloxetine (Drug)
Control group
Patients received a placebo capsule and an intravenous infusion of 200 mL of normal saline
干预措施: Placebo and normal saline (Drug)
结局指标
主要结局
Time to first analgesic request
时间窗: 48 hours postoperatively
Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administared).
次要结局
- Total morphine consumption(48 hours postoperatively)
- Degree of pain(48 hours postoperatively)
- Incidence of post-mastectomy pain syndrome(12 weeks postoperatively)
- Degree of patient satisfaction(48 hours postoperatively)
- Incidence of adverse events(at 8 weeks postoperative and 12 weeks postoperative)
研究者
Norma Osama Abdalla Zayed
Lecturer of Anesthesia, Surgical ICU and Pain Management, National Cancer Institute, Cairo University
National Cancer Institute, Egypt