Erector Spinae Plane Block (ESP) Versus Thoracic Epidural Anesthesia in Video-Assisted Thoracoscopic Surgery (VATS) in Pediatric Population; a Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Post-operative pain
研究概览
简要总结
Aim of the study is to investigate the efficacy and safety of continuous ESP block in children under the age of 10 yrs undergoing video-assisted thoracoscopic procedures, compared to Thoracic Epidural Anesthesia (TEA).
详细描述
Primary outcome:
Post-operative pain assessed by FLACC (Face, Legs, Activity: Cry, Consolability) for children age 1-5 years, and NRS (numerical rating scale) for children age 6-10 years
Secondary outcomes:
- Opioid consumption for 48 hours post-operatively.
- Intraoperative opiod use
- Block failure rate (defined as Heart Rate (HR) increase of more than 20% of baseline at surgical incision)
- Time to extubation after surgery completion After parental consent, children aged 0-10 yrs scheduled for unilateral VATS procedure will be randomized into two groups: Thoracic Epidural Group (TEA) vs Erector Spinae Plane block (ESP).
Children with history of allergy to local anesthetics, systemic coagulopathy, infection at site of puncture, severe renal or liver disease, known rib cage malformations will be excluded from the study.
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
- None
入排标准
- 年龄范围
- 1 Month 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •Scheduled for Video-Assisted Thoracoscopic Procedure
- •Parental consent
排除标准
- •Parental refusal
- •History of allergy to local anesthetics
- •Systemic coagulopathy
- •Local infection at puncture site
- •Severe renal or liver disease
- •Known rib cage malformations
结局指标
主要结局
Post-operative pain
时间窗: First 48 hours after surgery
Postoperative pain will be assessed by FLACC (Face, Legs, Activity: Cry, Consolability) scale for children aged 1-5 years, and NRS (numerical rating scale) for children aged 6-10 years
次要结局
- Postoperative opiod consumption(First 48 hours after surgery)
- Intraoperative opiod use(Surgery duration)