Comparison Between the Analgesic Effect of Fascia Transversalis Block vs Caudal Block in Pediatrics Undergoing Inguinal Hernia Surgeries: Randomized Double-blinded Comparative Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to the first request for rescue analgesia
研究概览
简要总结
Despite the growing interest in interfascial blocks and their successful use in pediatric surgeries, no previous randomized clinical trials have directly compared the analgesic efficacy, opioid-sparing effect, and safety profile of the fascia transversalis block versus the caudal block in pediatric patients undergoing unilateral inguinal hernia repair. This study aims to address this gap by providing the first head-to-head randomized comparison between both blocks in a standardized surgical setting
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
- Double (Participant, Outcomes Assessor)
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
- •ASA physical status I or II, scheduled for elective unilateral inguinal hernia surgery under general anesthesia
排除标准
- •Parental refusal.
- •Pre-existing infection at block site.
- •Coagulopathy (defined as INR >1.5, Platelets <100,000).
- •Known allergy to local anesthetics.
- •History of complications from regional anesthesia.
- •Emergency or bilateral hernia repair.
- •Neurodevelopmental disorders (e.g., cerebral palsy, spina bifida).
研究组 & 干预措施
Fascia Transversalis Block
Patients will receive Fascia Transversalis Block
干预措施: Fascia Transversalis Block (Procedure)
caudal block
Patients will receive caudal block
干预措施: Caudal Block Anesthesia (Procedure)
结局指标
主要结局
Time to the first request for rescue analgesia
时间窗: 24 hours post-operatively
the interval between the end of surgery (extubation) and the first need for analgesia (paracetamol)
次要结局
- Total intraoperative fentanyl consumption(from the start of general anesthesia until the extubation)
- Postoperative FLACC (Face, Legs, Activity, Cry, Consolability) pain scores(24 hours postoperatively)
- Total paracetamol dose in 24 hours(24 hours postoperatively)
- Parental satisfaction score(24 hours postoperatively)
研究者
AbdElKhalik Mahmoud Shaban
Lecturer of anaesthesia
Cairo University