Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The time to perform the block
研究概览
简要总结
The aim of this study is to compare the effect of epidural analgesia versus low-dose spinal analgesia in parturient in the late first stage of labor regarding time needed to perform the block, duration of the intra- and postoperative analgesia and incidence of procedure related adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Parturient with normal vaginal delivery in late first stage of labor (cervical dilatation ≥ 6 cm by examination)
- •Aged 18-40 years old
- •Single, term pregnant with normal fetal heart rate
- •Request neuroaxial analgesia
排除标准
- •Parturient who refuses to participate,
- •American Society of Anesthesiologists (ASA) physical status >II,
- •Body mass index more than 35 kg/m2
- •Severe pre-eclampsia or eclampsia
- •Uncontrolled thyrotoxicosis
- •Cardiovascular troubles (e.g. stenotic valvular heart disease or cardiomyopathy)
- •Increased intracranial tension due to a space-occupying lesion
- •Any contraindication to regional anesthesia such as local skin or soft tissue infection, coagulopathy or receiving anticoagulant therapy, thrombocytopenic, uncorrected hypovolemia, preexisting neurologic deficits, spinal deformity or previous spine surgery.
- •Hypersensitivity to the study drugs
- •Parturient who scheduled for emergency cesarean section due to fetal distress, antepartum hemorrhage, multiple gestation or fetal malpresentation
研究组 & 干预措施
Epidural Anesthesia
Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL
干预措施: Epidural Anesthesia (Procedure)
Spinal Anesthesia
Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.
干预措施: Spinal Analgesia (Procedure)
结局指标
主要结局
The time to perform the block
时间窗: Intraoperative
The time from the preparation of the block until the full injection of anesthetic drugs,
次要结局
- Number of participnts with Postoperative nausea and vomiting (PONV)(First 24 hours postoperatively)
- Mean arterial blood pressure (MAP)(Intraoperative)
- Heart rate (HR)(Intraoperative)
研究者
Amin Mohammed Alansary Amin Ahmed Helwa
Associate Professor
Ain Shams University