Decreasing the Invasiveness of Ultrasound Guided Caudal Block: A Randomized Controlled Trial Comparing Between 22-gauge and 27-guage Needles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Peri-operative complications
研究概览
简要总结
Ultrasound (US) has facilitated the use of caudal block in children and visualization of the needle during insertion. This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.
详细描述
Ultrasound (US) has facilitated the use of caudal block in children, allowing an initial assessment of the anatomy of the sacrum, including the relationship of the sacral hiatus to the dural sac ending. Real-time US allows visualization of the needle during insertion to reach the dural sac, and to see the turbulence and distention of the layers during injection of the local anesthetic drug.
This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.
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 (Participant)
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 6 months and 36 months
- •Undergoing elective lower abdominal or perineal surgeries
排除标准
- •Refusal of the legal guardian of the patient.
- •Patients aging less than 6 months, or older than 36 months.
- •Emergency surgeries.
- •Coagulopathy.
- •infection at the site of procedure.
- •Uncorrected hypovolemia.
- •Increased intracranial pressure.
- •Congenital anomalies at the site of procedure.
结局指标
主要结局
Peri-operative complications
时间窗: 210 minutes
Peri-operative complications related to the caudal block procedure will be documented from the start of the procedure till the discharge from the post-anesthesia care unit.
Opioids requirements intraoperatively
时间窗: 90 minutes
The investigators will document the required dose of opioids intraoperatively
Pain score in the post-anesthesia care unit (PACU)
时间窗: 120 minutes
Pain score will be assessed regularly during the stay in the PACU using a pain scoring scale, where the score is interpreted from 0 to 10, in which 0 means no pain and 10 signifies very severe pain.
次要结局
未报告次要终点
研究者
omar ahmad ababneh
Principal investigator
University of Jordan