Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- postoperative pain management
研究概览
简要总结
To study the efficacy of magnesium sulphate as adjuvant to levobupivacaine in transversus abdominis plane (TAP) block in patient undergoing abdominal cancer surgery.
详细描述
In this randomized study, patients with (ASA) Ӏ and ӀӀ, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled.
A written informed consent from all parents are obtained
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
all participant will be blinded to the study drugs.
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with (ASA) Ӏ and ӀӀ physical status, aged from 1 to 7 years old and their weight less than 30 Kg of both sex will undergo surgery will be enrolled.
排除标准
- •Children with infection, hemorrhagic disorders, hypersensitivity to the studied drugs, muscular disorders, central and peripheral neuropathy, organ dysfunction, cardiac problems and unconscious or mentally retarded patients will be excluded
研究组 & 干预措施
magnesium sulphate& levobupivacaine
Levobupivacaine add to magnisum sulphate
干预措施: magnesium sulphate& levobupivacaine (Drug)
magnesium sulphate& levobupivacaine
Levobupivacaine add to magnisum sulphate
干预措施: ultra-sound guided transversus abdominis plan block (Procedure)
levobupivacaine
levobupivacaine
干预措施: ultra-sound guided transversus abdominis plan block (Procedure)
levobupivacaine
levobupivacaine
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
postoperative pain management
时间窗: one day
pain will be assessed using FLACC score.The Face, Legs, Activity, Cry, Consolability (FLACC) pain score with its 0 - 10 score range will be used to assess pain immediately postoperative and then at 2, 4, 6, 8, 12, 18 and 24 hours in the postoperative period.
次要结局
未报告次要终点
研究者
Ahmed Kamal Sayed
Principal Investigator
South Egypt Cancer Institute