Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics Undergoing Inguinal Hernia Repair: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Total postoperative pethidine consumption
研究概览
简要总结
The aim of this study is to compare laparoscopic -assisted, ultrasound-guided transversus abdominis plane block and laparoscopic intraperitoneal instillation of local anesthetic in pediatrics undergoing inguinal hernia repair.
详细描述
Inguinal hernia is one of the most common pediatric surgeries. Effective and safe pain management causes fewer side effects and enables faster hospital discharge. It is also important in overcoming chronic pain in the late postoperative period.
Transversus abdominis plane block (TAPB) has emerged as a safe, simple, and inexpensive modality incorporated into many enhanced recovery pathways to achieve narcotic-sparing analgesia after bariatric surgery. TAPB was first performed through the lumbar triangle of Petit in 2001. Since that time, both ultrasound-guided (US) and laparoscopic (LAP) TAPBs have been developed to aid in proper identification of the correct plane and minimize peritoneal penetration.
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
- 2 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 2 months to 7 years old
- •Both sexes.
- •American Society of Anesthesiologists (ASA) I-II.
- •Schedule for elective unilateral inguinal hernia repair.
排除标准
- •Patients with history of allergy.
- •Hepatic and renal failure.
- •Previous inguinal surgery.
- •Block contraindications (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).
研究组 & 干预措施
Ultrasound-guided transversus abdominis plane block
This group will receive Ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group.
干预措施: Bupivacaine (Drug)
Ultrasound-guided transversus abdominis plane block
This group will receive Ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group.
干预措施: Ultrasound-guided transversus abdominis plane block (Procedure)
Laparoscopic-assisted transversus abdominis plane block
Patients will receive Laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL.
干预措施: Laparoscopic-assisted transversus abdominis plane block (Procedure)
Laparoscopic-assisted transversus abdominis plane block
Patients will receive Laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL.
干预措施: Bupivacaine (Drug)
Laparoscopic-assisted intraperitoneal instillation
This group will receive Laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation.
干预措施: Laparoscopic-assisted intraperitoneal instillation (Procedure)
Laparoscopic-assisted intraperitoneal instillation
This group will receive Laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Total postoperative pethidine consumption
时间窗: 24 hours postoperatively
The patient will be given supplementary paracetamol I.V. injection in a dose of 15 mg/kg as routine analgesia. If the FLACC score is \> 3, pethidine 0.5 mg/kg.
次要结局
- Post-operative pain scores(24 hours postoperatively)
- Time of first analgesia request.(24 hours postoperatively)
- Incidence of adverse events(24 hours postoperatively)
研究者
ِAhmed Mohamed Ibrahim
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University