COMPARISON OF ANALGESIC EFFECTS OF WOUND INFILTRATION WITH ROPIVACAINE VERSUS CAUDAL BLOCK WITH ROPIVACAINE IN PEDIATRIC PATIENTS UNDERGOING INGUINAL HERNIOTOMY INTRODUCTION
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative Analgesic Requirement
研究概览
简要总结
This randomized controlled trial aims to compare the analgesic efficacy of local wound infiltration with Ropivacaine versus Caudal Block with Ropivacaine in pediatric patients undergoing surgery for inguinal hernia
详细描述
Pediatric patients undergoing inguinal hernia surgeries experience postoperative pain. Conventional pain management methods, including opiates, may pose significant side effects. This study addresses the imperative need for optimizing postoperative pain management by systematically investigating and comparing the analgesic effects of local wound infiltration versus caudal block. The study involves 100 patients allocated into two equal groups using a lottery method: one group receiving caudal block; and other group local wound infiltration . Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.
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 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 2-10 years.
- •Patients undergoing open elective herniotomy.
- •Patients classified as ASA (American Society of Anesthesiologists) classes I and II.
排除标准
- •Patients with recurrent, bilateral, complicated, or obstructed hernias.
- •History of bleeding disorders.
- •Presence of congenital anomalies of the spine.
- •History of drug allergy.
- •Infection at the caudal injection site.
研究组 & 干预措施
Group B: Local wound infiltration
Pediatric patients undergoing open elective inguinal herniotomy who receive post-operative local wound infiltration.
干预措施: Intravenous Paracetamol Suspension Intervention (Drug)
Group A: Caudal Block Group
Pediatric patients undergoing open elective inguinal herniotomy who receive a post-operative caudal block.
干预措施: Caudal Block with Ropivacaine Intervention (Drug)
Group A: Caudal Block Group
Pediatric patients undergoing open elective inguinal herniotomy who receive a post-operative caudal block.
干预措施: Intravenous Paracetamol Suspension Intervention (Drug)
Group B: Local wound infiltration
Pediatric patients undergoing open elective inguinal herniotomy who receive post-operative local wound infiltration.
干预措施: Local Wound Infiltration with Ropivacaine Intervention (Drug)
结局指标
主要结局
Postoperative Analgesic Requirement
时间窗: Within first 8 hours after surgery
Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.
Postoperative Analgesia requirement
时间窗: Within first 8 hours after surgery
Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.
次要结局
未报告次要终点
研究者
Rimsha Zafar
COMPARISON OF ANALGESIC EFFECTS OF WOUND INFILTRATION WITH ROPIVACAINE VERSUS CAUDAL BLOCK WITH ROPIVACAINE IN PEDIATRIC PATIENTS UNDERGOING INGUINAL HERNIOTOMY INTRODUCTION
Fatima Memorial Hospital