Efficacy and Safety of General Anesthesia With Caudal Block for Inguinal Hernioplasty in Children: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
This is a prospective, randomized, controlled clinical study designed to determine the effectiveness of caudal block combined with general anesthesia in providing intra- and postoperative analgesia, and its effect on hemodynamic stability and drug consumption.
详细描述
This prospective, randomized, controlled clinical study will include 70 boys aged 3-5 years scheduled for inguinal herniorrhaphy. Participants will be randomized in 1:1 ratio into two groups. The first group will receive general anesthesia for surgery, while the second group will receive general anesthesia in combination with caudal block. Postoperative pain, hemodynamic parameters and total consumption of all medicaments in the perioperative period will be monitored. Complications and side effects of drugs will be observed as well.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •boys between 3 to 5 years old
- •scheduled for elective inguinal hernioplasty
- •without comorbidities and chronic therapy, ASA class I
- •body mass and growth normal for the given age
- •no allergies
- •no congenital anomalies and birth complications
排除标准
- •emergency surgeries
- •surgeries longer than 60 minutes
- •acute infections with leucocytosis/leucopenia
- •acute or chronic diseases
- •deformities and disorders of spine and nervous system
- •allergies
- •pilonidal cyst and/or inflammation in sacral region
研究组 & 干预措施
General anesthesia + caudal block
General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg), in combination with a single shot caudal block with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg).
干预措施: Caudal block with levobupivacaine (Drug)
General anesthesia + caudal block
General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg), in combination with a single shot caudal block with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg).
干预措施: General anesthesia (Drug)
General anesthesia + caudal block
General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg), in combination with a single shot caudal block with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg).
干预措施: Inguinal hernioplasty (Procedure)
General anesthesia
General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg)
干预措施: General anesthesia (Drug)
General anesthesia
General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg)
干预措施: Inguinal hernioplasty (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: 5 hours
Postoperative pain level measured using the Wong-Baker Faces pain rating scale
次要结局
- Blood pressure(5 hours)
- Heart rate(5 hours)
研究者
Mihaela Preveden
Research Assistant
University of Novi Sad