Caudal vs. Pudendal Block for Early Postoperative Pain Control in a Pediatric Population Undergoing Lower Genitourinary Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rescue Narcotic Administration
研究概览
简要总结
This study will compare two techniques to minimize pain during and after penile surgery in children undergoing certain urologic surgeries. These two approaches include the caudal nerve block and the pudendal nerve block.
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
- 6 Months 至 3 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Undergoing penile genitourinary surgery
- •ASA class 1-3
排除标准
- •Female patients
- •Male children <6 months or >/= 3 years of age
- •ASA class >3
- •Surgery at satellite location (non-Prentiss)
- •Concurrent non-lower GU tract surgery
- •Sacrospinal abnormality
- •History of chronic pain requiring opioid analgesics
- •Inability to tolerate and receive acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), alpha-2 agonists, or local anesthetics
- •History of malignant hyperthermia
- •History of coagulopathy
研究组 & 干预措施
Caudal Block
Patients will receive a caudal block prior to surgery.
干预措施: Caudal Block (Procedure)
Caudal Block
Patients will receive a caudal block prior to surgery.
干预措施: Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine (Drug)
Pudendal Block
Patients will receive a pudendal block prior to surgery.
干预措施: Ultrasound-guided Pudendal Block (Procedure)
Pudendal Block
Patients will receive a pudendal block prior to surgery.
干预措施: Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine. (Drug)
结局指标
主要结局
Rescue Narcotic Administration
时间窗: During post-operative in-hospital recovery, approximately 1 hour
Dose (mg) of postoperative rescue opioid
次要结局
- Non-Narcotic Rescue Administration at 24 hours(During first day after surgery, approximately 24 hours)
- Non-Narcotic Rescue Administration at 48 hours(During second day after surgery, approximately 48 hours)
- Non-Narcotic Rescue Administration at 72 hours(During third day after surgery, approximately 72 hours)
- Number of participants with at least one adverse event (AE) as measured by patient report(End of study, up to 3 months)