Comparison of Two Fluid Strategies for Prevention of Post-dural Puncture Headache After Cesarean Delivery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of post-dural puncture headache
研究概览
简要总结
Postdural puncture headache (PDPH) is a common complication after cesarean delivery (CD). The role of peri-operative fluid therapy in prophylaxis against PDPH is unclear. The aim of this work is to compare restrictive versus liberal fluid therapy in prophylaxis against PDPH after CD
详细描述
In this study, the investigators will compare restrictive fluid therapy and liberal fluid therapy in prophylaxis against postdural puncture headache.
The restrictive group will not receive preoperative fluid loading, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour for hours. The Liberal group will receive preoperative fluid loading of 5 mL/Kg, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour, followed by postoperative crystalloids at rate of 6 mL/Kg/hour.
Both groups will be compared regarding demographic data, total peri-operative fluids, incidence of postdural puncture headache, nausea, vomiting, and intraoperative hemodynamics (heart rate and systolic blood pressure) in addition to neonatal outcomes.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Full term
- •Pregnant female
- •Scheduled to elective cesarean delivery
排除标准
- •History of migraine headache
- •Hypertensive disorders of pregnancy
- •Cardiac morbidities,
- •Baseline systolic blood pressure < 100 mmHg
- •Contraindication of regional anesthesia.
- •Patients with more than one single attempt for spinal block
研究组 & 干预措施
Restricted fluid therapy group
Restrictive fluid therapy: this group will not receive fluid pre-load, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2mL/Kg/hour.
干预措施: Restrictive fluid therapy (Drug)
Liberal fluid therapy group
Liberal fluid therapy: this group will receive fluid pre-load (5 mL/Kg), and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 6 mL/Kg/hour.
干预措施: Liberal fluid therapy (Drug)
结局指标
主要结局
Incidence of post-dural puncture headache
时间窗: 48 hours
the number of patients who develop post-dural puncture headache defined as pain scale above 4
次要结局
- Wong-Baker faces pain scale(48 hours)
- postoperative nausea and vomiting(24 hours)
- incidence of post-spinal hypotension(60 minutes)
- heart rate(24 hours)
研究者
Ahmed Hasanin
Assistant professor
Cairo University