The Effect of Preoperative Oral Melatonin on Postoperative Pain Control After Cesarean Section: A Dose Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity measured using the VAS (Visual Analogue Scale)
研究概览
简要总结
The goal of this clinical trial is to learn if melatonin will decrease pain after C.S. The main questions it aims to answer are:
Does melatonin lower the number of times participants need to use a rescue analgesia? What medical problems do participants have when taking melatonin? Researchers will compare different doses of melatonin to see the ideal dose to decrease pain after C.S.
Participants will:
Take melatonin 30 min before C.S and will be observed for 24 hours for pain and consumption of other analgesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Women aged 18-40 years.
- •Scheduled for elective cesarean section.
- •Ability to provide informed consent.
排除标准
- •Known hypersensitivity to melatonin or opioids
- •Chronic use of analgesics, sedatives, or antidepressants.
- •History of sleep disorders or psychiatric illness.
- •Complicated pregnancies (e.g., preeclampsia, gestational diabetes).
- •Body mass index (BMI) > 35 kg/m².
- •Emergency cesarean sections.
- •Severe systemic diseases (e.g., liver or kidney dysfunction).
研究组 & 干预措施
Group III: (Placebo)
干预措施: Placebo (Drug)
Group I: (5 mg melatonin)
干预措施: Melatonin 5 mg (Drug)
Group II: (10 mg melatonin)
干预措施: Melatonin 10 mg (Drug)
结局指标
主要结局
Postoperative pain intensity measured using the VAS (Visual Analogue Scale)
时间窗: 2, 6, 12, and 24 hours post-surgery.
it typically consists of a 100 mm straight line with descriptive anchors at each end representing the extremes of the sensation (for example, "no pain" at one end and "the most severe pain imaginable" at the other). Respondents indicate their experience by marking a point on the line, and the distance from the lower anchor is measured and recorded as a continuous variable
次要结局
- first rescue analgesia(the first 24 hours post operative)
- Total opioid consumption(the first 24 hours post operative)
- Incidence of adverse effects(first 24 hours post operative)
- Time to first ambulation post-surgery(first 24 hours post operative)
研究者
Taghreed Elshahat Sakr
lecturer of anesthesia
Benha University