A Comparative Study of Success Rate, Efficacy, Safety Between Electrical Stimulation-guided Epidural Catheter Placement and the Loss of Resistance Conventional Method for Vaginal Delivery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Success rate of epidural analgesia
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 electrical stimulation group (n=20). Pain will be assessed using a numerical visual analog scale and maternal satisfaction by a post-partum interview. The success rate of epidural analgesia, 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 electrical stimulation.
Epidural catheter placement, electrical 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 Loss of resistance (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 Tuohy needle.
The same process will be followed for the Epidural electrical stimulation (EES) group. In addition, the epidural space will be confirmed by epidural electrical 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who were at 36 to 41 weeks' gestation and admitted in labor to the university clinic for vaginal delivery were included. Patients were American Society of Anesthesiologists (ASA) physical status of I or II, and were scheduled to receive epidural analgesia
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
- •Injection of an analgesic within the previous 12 hours
- •Presence of a cardiac pacemaker
结局指标
主要结局
Success rate of epidural analgesia
时间窗: Up to 6 months
Evaluation parameter : Accuracy comparison between loss of resistance and epidural electrical stimulation
次要结局
- Neonatal Apgar score(Up to 6 months)
- Procedure-related complications(Up to 6 months)
- Minimum electrical current to elicit a response in the epidural electrical stimulation group(Up to 6 months)
- Additional time for epidural electrical stimulation(Up to 6 months)
- Maternal satisfaction(Up to 6 months)
研究者
Sang Sik Choi
Professor
Korea University Guro Hospital