Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- FLACC scale FLACC scores will be recorded. FLACC scores will be recorded. FLACC score will be recorded
研究概览
简要总结
Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (e.g. post-operative apnea). The use of spinal anesthesia in infants and children requiring surgeries of the sub-umbilical regions is gaining considerable popularity worldwide. Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Bupivacaine has been thoroughly studied, and a large global experience exists.
详细描述
Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (post-operative apnea). In this population, spinal anesthesia has been proposed as a means to reduce post-operative complications, especially apnea and post-operative respiratory dysfunction, although this utility has been questioned.
Spinal anesthesia modifies the neuroendocrine stress response, ensures a more rapid recovery, and may shorten hospital stay with fewer opioid-induced side effects.
Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide an-algesia for approximately 4-6 hours.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 2-10 years.
- •Weight: 15-40 kg.
- •Sex: both males and females.
- •ASA physical status: 1-II.
- •Operation: surgery below the umbilicus.
排除标准
- •Allergic reaction to local anesthetics (LAs).
- •Local or systemic infection (risk of meningitis).
- •Intracranial hypertension.
- •Hydrocephalus.
- •Intracranial hemorrhage.
- •Coagulopathy.
- •Hypovolemia.
- •Parental refusal.
- •Spinal deformities, such as spina bifida or myelomeningocele.
- •Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.
研究组 & 干预措施
spinal group
Plain, isobaric levobupivacaine(0.25%) 0.25 mg/kg
干预措施: Levobupivacaine (Drug)
caudal group
Plain, isobaric levobupivacaine (0.25%) 1 ml/kg
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
FLACC scale FLACC scores will be recorded. FLACC scores will be recorded. FLACC score will be recorded
时间窗: 24 hours postoperative
Face, Legs, Activity, Cry, Consolability scale will be recorded. Each category is scored on the 0 to 2 scale. Add the scores together (for a total possible score of 0 to 10).
次要结局
- Total consumption of rescue analgesics(24 hours)
研究者
Ghada Mohammed AboelFadl
Principal investigator
Assiut University