Handheld Ultrasound-assisted Versus Palpation-guided Labor Combined Spinal-epidural Analgesia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Total duration of combined spinal-epidural procedure
研究概览
简要总结
Parturients who need combined spinal-epidural analgesia for labour analgesia are randomly assigned to two groups. For the handheld ultrasound-assisted technique group, ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle. For the conventional palpation-guided technique group, the interspinous space is detected by palpation. Procedure time, the number of needle passes, the number of needle insertion attempts, success rate, and complications are compared.
详细描述
This study aims to determine whether handheld ultrasound-guidance can reduce procedural time for labor combined spinal-epidural analgesia compared with conventional surface landmark-guided technique.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult parturients with ASA physical status classification I, II or III requiring a combined spinal-epidural for labor analgesia
排除标准
- •Contraindication to neuraxial anesthesia (local anesthetics hypersensitivity, coagulopathy, needle insertion site infection, etc.)
- •Difficulty in communication
- •Severe cardiac disease
- •History of spine surgery
- •Anatomical abnormality of the lumbar spine
- •Age under 18
结局指标
主要结局
Total duration of combined spinal-epidural procedure
时间窗: During procedure
Identifying time (time required to complete the preprocedural spinal ultrasound or the assessment by palpation) + Procedural duration (time from the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter)
次要结局
- Identifying time(During procedure)
- Success rate at the first attempt(During procedure)
- Number of needle insertion attempts(During procedure)
- Need to use alternative methods(During procedure)
- Actual needle depth (cm)(During procedure)
- Procedural duration(During procedure)
- Success rate at the first needle pass(During procedure)
- Number of interspace levels at which the insertion was attempted(During procedure)
- Success rate of dural puncture with needle-through-needle technique(During procedure)
- Incidence of radicular pain, paresthesia, and bloody tapping(During procedure)
- Procedural pain using 11-point verbal rating scale(During procedure)
- Number of passes(During procedure)
- Procedural discomfort using 11-point verbal rating scale(During procedure)
- Patient satisfaction using 11-point verbal rating scale(From the end of the procedure to delivery)
- Depth by ultrasound(During procedure)
- Failure of labor analgesia(Within 2 hours after the procedure)
- Incidence of inadvertent dural puncture(During procedure)
- Incidence of postdural puncture headache(Up to 2 weeks)
- Incidence of back pain postpartum at the site of epidural insertion(Up to 2 weeks)
研究者
Sun-Kyung Park
Professor
Seoul National University Hospital