Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy: A Randomized Controlled Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to the 1st rescue analgesia
研究概览
简要总结
The aim of this study is to compare ultrasound-guided transversalis fascia plane block and caudal block for postoperative analgesia in children undergoing inguinal herniorrhaphy.
详细描述
Surgical repair of inguinal hernia is one of the most common day-case surgeries in the pediatric population. It is associated with significant postoperative pain and discomfort.
Caudal block analgesia is a popular and reliable technique for lower abdominal surgeries and found to be safe and effective for providing intra and postoperative analgesia in pediatric patients.
transversal fascia plane block (TFPB) aims to provide analgesia for invasive procedures of the inguinal and sublingual areas by blocking the subcostal (T12), ilioinguinal (L1) and iliohypogastric (T12-L1) nerves. Several studies have reported TFPB as the analgesic method of choice for procedures involving the T12-L1 dermatome region, including iliac bone graft harvesting, cesarean section, and inguinal hernia repair
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
- •Age from 1 to 7 years.
- •Both sexes.
- •American Society of Anesthesiology (ASA) physical status I-II.
- •Scheduled for inguinal herniorrhaphy under general anesthesia (GA).
排除标准
- •Repeated surgeries.
- •Known allergic reactions to any of the study's drugs.
- •Infection at the site of block needle entry.
- •Bleeding diathesis.
- •Neurological disorders.
研究组 & 干预措施
Transversalis fascia plane block group
Patients will receive transversalis fascia plane block after the induction of general anesthesia.
干预措施: Transversalis fascia plane block (Other)
Caudal block group
Patients will receive caudal block after the induction of general anesthesia.
干预措施: Caudal block (Other)
结局指标
主要结局
Time to the 1st rescue analgesia
时间窗: 24 hours postoperatively
Time to the first request for the rescue analgesia (time from the end of surgery to first dose of paracetamol administrated).
次要结局
- Degree of pain(24 hours postoperatively)
- Total paracetamol consumption(24 hours postoperatively)
- Intraoperative fentanyl consumption(Intraoperatively)
- Hear rate(Every 15 min till the end of surgery (Up to 2 hours))
- Mean arterial pressure(Every 15 min till the end of surgery (Up to 2 hours))
- Degree of patient's parents satisfaction(24 hours postoperatively)
- Incidence of adverse events(24 hours postoperatively)
研究者
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University