NCT04614259Unknown不适用
Perioperative Pain Management for Cleft Lip Repair in Children, Bilateral Infraorbital Nerve Block Versus Conventional Methods( Combined IV Fentanyl With Peri Incisional Infiltration). A Randomized Comparative Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 主要终点
- Postoperative opioid consumption
研究概览
简要总结
Single blind prospective randomized comparative study. 76 children between 6 months and 3 years with cleft lip will be divided in two groups. 38 children group C conventional group and 38 children group S infraorbital nerve block group.
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 (Investigator)
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good physical condition.
- •Age 6 months to 3 years.
- •Scheduled to undergo operations for cleft lip repair. Genders eligible for study are both .
排除标准
- •Children posted for combined procedures like congenital heart correction with palatoplasty .
- •Parents refusal .
- •Bleeding disorders( platelets count < 100.000 , international ratio >1.5).
- •Skin lesions or wounds at site of needle insertion .
- •Co-morbidities as congenital heart disease , lung pathology or central nervous system
- •Known hypersensitivity to local anesthetics or opioids .
研究组 & 干预措施
intravenous analgesia
Experimental
干预措施: i.v. analgesia (Combination Product)
infraorbital nerve block
Experimental
干预措施: Bupivacain (Drug)
结局指标
主要结局
Postoperative opioid consumption
时间窗: 24 huors
Total rescue doses of morphine
次要结局
未报告次要终点
研究者
Mohamed Elsonbaty
Principal investigator
Cairo University
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