Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain: Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in post-cesarean pain
研究概览
简要总结
*Aim of the Work This study aims to assess the efficacy of intravenous injection of dexamethasone prior to spinal anesthesia in reducing post-cesarean section pain in women undergoing cesarean section.
详细描述
*Research Hypothesis: In women undergoing cesarean section, intravenous injection of dexamethasone prior to spinal anesthesia may reduce post-cesarean section pain.
*Research Question: In women undergoing cesarean section, does injecting intravenous dexamethasone prior to spinal anesthesia reduce post-cesarean section pain?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A gestational age of 38 weeks or more and planned for elective cesarean section.
- •Living fetus.
- •Any number of previous cesarean section.
- •Intact amniotic membranes.
- •No history of bleeding tendency.
排除标准
- •Refuse to participate after counseling.
- •Contraindication to spinal anesthesia (coagulopathy significant hypovolemia systemic or local sepsis - increased intracranial pressure - local anesthetic or fentanyl allergy).
- •High risk pregnancies as pre-eclampsia, any medical disorder (diabetes mellitus, cardiac disease or and thyroid disease).
- •Contraindication to corticosteroids e.g. systemic fungal infection
- •Steroid medication one week before the operation.
- •Chronic pain or daily intake of analgesic.
- •Abnormal placentation e.g. placenta previa.
- •Intrauterine infection.
研究组 & 干预措施
Group (D)
will include 50 women who will receive intravenous dexamethasone.
干预措施: Dexamethasone (Drug)
Group (C)
will include 50 women who will receive intravenous normal saline (0.9 %).
干预措施: Normal Saline (Other)
结局指标
主要结局
change in post-cesarean pain
时间窗: 2, 4, 8 and 12 hours after the procedure
post-cesarean pain degree scored by the patient on Visual Analogue Scale
次要结局
- shivering(2, 4, 8 and 12 hours after the procedure)
- vomiting(2, 4, 8 and 12 hours after the procedure)
- sensory recovery(2, 4, 8 and 12 hours after the procedure)
- motor recovery(2, 4, 8 and 12 hours after the procedure)
- nausea(2, 4, 8 and 12 hours after the procedure)
研究者
Abdelhameed Ahmed Ali Ismail
Dr
Ain Shams Maternity Hospital