Post-cesarean Section Analgesic Potency and Side Effects of Intrathecal Morphine and Nalbuphine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
The primary endpoint of this study is to investigate the effect of adding nalbuphine to intrathecal morphine on quality of postoperative analgesia and Morphine related side effects post- cesarean delivery.
详细描述
The study will be performed in Assiut University Hospitals, after obtaining approval from the local ethics committee and written informed patient consent. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. All the patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. Intrathecal block under strict aseptic conditions will be performed in sitting position at L3-4 or L4-5 inter-spinous space with 25G pencil-point spinal needle. All patients will receive intrathecal 10 mg of 0.5% hyperbaric bupivacaine.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •age between 16 to 40 years
- •ASA physical status I - II
排除标准
- •Infection at the site of injection.
- •Coagulopathy or other bleeding diathesis.
- •Preexisting neurologic deficits.
- •History of hypersensitivity to any of the given the drugs.
- •Inability to communicate with the investigator and the hospital staff.
- •History of chronic opioid us
研究组 & 干预措施
Group 1
Morphine group
干预措施: Morphine (Drug)
Group 2
Morphine plus Nalbuphine group
干预措施: Morphine plus Nalbuphine (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 24 hours
Visual Analogue Score
次要结局
- Incidence of postoperative itching(24 hours)
- number of participants with incidence of postoperative nausea(24 hours)
- number of participants with incidence of postoperative vomiting(24 hours)
- number of participants with incidence of postoperative postdural puncture headache(24 hours)
- number of participants with incidence of postoperative respiratory depression(24 hours)
研究者
Abdelrady S Ibrahim, MD
Assistant professor of Anesthesia and ICU
Assiut University