Comparison of TAP Block With Two Different Doses of Levobupivacaine for Postoperative Pain Management in Pediatric Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 主要终点
- postoperative VAS score <4 at postoperative 24 hours
研究概览
简要总结
The aim of the current study is to investigate the effects of two different doses of levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For this purpose we planned to include 50 children aged between 2 and 12 that will undergo unilateral inguinal surgery.
The doses that will be used in the study were within usual dose limits which is stated in prospectus of the study drug.
详细描述
Fifty children undergoing TAP block were randomly divided into two groups as levobupivacaine 0.25% 0.5 ml/kg and levobupivacaine 0.25% 0.25 ml/kg. Postoperative pain was evaluated with observational pain scale and modified pediatric objective pain scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers planned to undergo unilateral inguinal surgery under TAP (ilioinguinal and iliohypogastric block) and general anesthesia
- •Aged between 2 and 12
排除标准
- •Patients with coagulation dysfunction
- •Patients with chronic pain
- •Patients having infection at the site of intervention
- •Patients with a history of allergy
- •Patients having chronic diseases (hepatic dysfunction, renal failure)
研究组 & 干预措施
Group Levobupivacaine high volume
TAP block with levobupivacaine 0.25% of 0.5 ml/kg under general anesthesia
干预措施: Levobupivacaine (Drug)
Group Levobupivacaine low volume
TAP block with levobupivacaine 0.25% of 0.25 ml/kg under general anesthesia
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
postoperative VAS score <4 at postoperative 24 hours
时间窗: Postoperative first 24 hours
次要结局
未报告次要终点