Comparison Between Ultrasound-assisted and Conventional Palpation Techniques for Epidural Catheterization Before Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Rate of successful epidural catheterization at the first needle pass
研究概览
简要总结
The study will assess the benefit of using spinal ultrasound before epidural catheter insertion compared to the conventional palpation technique in women undergoing cesarean section.
详细描述
The study will compare the ultrasound-assisted and the conventional palpation techniques for epidural catheterization as a component of combined spinal-epidural anesthesia for cesarean section.
Participants will be randomly assigned into 2 equal groups. In the ultrasound group: Preprocedure lumbar spinal ultrasound will be performed before epidural catheterization. In the palpation group: Conventional technique of landmark palpation will be used.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists class I or II.
- •Full term parturients scheduled for elective cesarean delivery under combined spinal-epidural anesthesia.
排除标准
- •Body mass index ≥ 35 kg/m
- •Patients having any contraindication to neuraxial anesthesia (Refusal of the procedure, Coagulopathy, Uncorrected hypovolemia, Increased intracranial pressure, Local skin infection).
- •Marked spinal deformity or previous spinal surgery.
- •Unpalpable anatomical landmarks.
- •Emergent situations.
结局指标
主要结局
Rate of successful epidural catheterization at the first needle pass
时间窗: 24 hours after delivery
Needle pass includes any forward advancement of the Tuohy needle.
次要结局
- Patient satisfaction (5-point scale)(24 hours after delivery)
- Rate of Inadvertent dural puncture(24 hours after delivery)
- Rate of Back pain(24 hours after delivery)
- Number of needle passes required for successful epidural catheterization(24 hours after delivery)
- Rate of Failed block(At the first request of analgesia)
- Rate of successful epidural catheterization at the first skin puncture(24 hours after delivery)
- Number of skin punctures required for successful epidural catheterization(24 hours after delivery)
- Time of the epidural catheterization procedure(24 hours after delivery)
- Unilateral / Patchy block (Assessed by pinprick)(At the first request of analgesia)
- Rate of Inadvertent vascular puncture(24 hours after delivery)
研究者
Mohamed Mohamed Tawfik
Lecturer
Mansoura University