A Comparative Study of Success Rate, Efficacy, Safety Between Electric Stimulation-guided Epidural Catheter Placement and the Loss of Resistance Conventional Method for Cesarean Section
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Success rate of epidural anesthesia
研究概览
简要总结
Forty pregnant women (36 to 41 weeks gestation) will randomly allocate to two groups. Groups will be defined based on the method used to identify the epidural space for epidural anesthesia: the loss of resistance group (n=20) and the epidural electric stimulation group (n=20). Pain during the cesarean section will be assessed using a numerical visual analog scale and maternal satisfaction by a post-partum interview. The success rate of epidural anesthesia, maternal satisfaction, and neonatal Apgar scores will be compared between groups.
详细描述
Investigators will place epidural catheter in the epidural space using loss of resistance technique, and will confirm correct placement of the epidural catheter using electric stimulation.
Epidural catheter placement, electric stimulation, and confirmation of response is followed:
Patients will be placed in the left lateral decubitus position. The site will be aseptically prepared and 1% lidocaine will be infiltrated to the skin. An 18-gauge Tuohy needle will be inserted midline of L4/5 interspinous space.
For the LOR group, after identification of the epidural space, the Tuohy needle will be stopped, and a 20-gauge epidural catheter will be advanced through the Touhy needle.
The same process will be followed for the EES group. In addition, the epidural space will be confirmed by epidural electric stimulation using a 20-gauge epidural catheter (RegionalStimTm, Sewoon Medical Co., Ltd, Seoul, Korea, 800 mm) with a conductive guidewire (conductive guidewire, Nitinol, 1100 mm).
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
- None
盲法说明
No Masking
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who were at 36 to 41 weeks' gestation and admitted in labor to the university clinic for cesarean section were included. Patients were American Society of Anesthesiologists (ASA) physical status of I or II, and were scheduled to receive epidural anesthesia.
排除标准
- •Skin infection at the injection site
- •Difficult catheter placement owing to previous lumbar spinal surgery or deformity
- •Presence of a hemostatic disorder or use of antiplatelet therapy
- •Presence of a cardiac pacemaker.
- •Removal of patient
研究组 & 干预措施
Epidural electrical stimulation (EES)
n=20
干预措施: Epidural electrical stimulation (EES) (Device)
Loss of resistance (LOR)
n=20
干预措施: Loss of resistance (LOR) (Device)
结局指标
主要结局
Success rate of epidural anesthesia
时间窗: Up to 6 months
Evaluation parameter : Accuracy comparison between loss of resistance and epidural electrical stimulation
次要结局
- Procedure-related complications(Up to 6 months)
- Maternal satisfaction(Up to 6 months)
- Neonatal Apgar score(Up to 6 months)
- Additional time for epidural electrical stimulation(Up to 6 months)
- Minimum electrical current to elicit a response in the epidural electrical stimulation group(Up to 6 months)
研究者
Sang Sik Choi
Professor
Korea University Guro Hospital