Comparison of Analgesic Efficacy of Sacral Erector Spinae Plane Block and Caudal Epidural Block in Pediatric Patients Undergoing Hypospadias Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The pain status of patients in both groups will be evaluated with the FLACC score at postoperative 1, 2, 4, 6, 12 and 24 hours.
研究概览
简要总结
The goal of this observational study is to learn about effects of block strategies (sacral erector spinae plane block - ESP, caudal block) on perioperative pain in pediatric patients undergoing hypospadias surgery. The main question it aims to answer is:
Is there a difference in analgesic efficacy between sacral erector spinae plane block and caudal block in pediatric patients undergoing hypospadias surgery? Eighty six pediatric patients (ages 1-7 years, ASA I-II) scheduled for hypospadias repair under general anesthesia were included in this prospective randomized study. Both blocks were performed using 0.25% bupivacaine, at doses of 0.5 mL/kg for our study. Pain was assessed using the FLACC scale at 1, 2, 4, 6, 12 and 24 hours postoperatively.
详细描述
Postoperative pain management in pediatric urological surgery, particularly in hypospadias repair, is essential for reducing distress, minimizing analgesic requirements, and promoting early recovery. Caudal epidural block remains the gold standard for postoperative analgesia in this patient population due to its well-established safety and efficacy. However, its limitations-such as the risk of motor block, urinary retention, and unpredictable spread of local anesthetic-have encouraged the exploration of alternative regional techniques.
The sacral erector spinae plane (ESP) block, first described for thoracic and lumbar analgesia, has recently been applied in the sacral region as a novel approach for pediatric surgeries involving the perineum and genital area. The block is technically simpler, avoids the epidural space, and carries a low risk of complications. Nevertheless, data comparing its efficacy with the traditional caudal block in hypospadias surgery remain limited.
This study aimed to compare the analgesic efficacy and safety of sacral ESP block and caudal epidural block in children undergoing hypospadias repair surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Children aged 1-7 years
- •Classified as ASA physical status I-II
- •Scheduled for primary hypospadias repair were enrolled
排除标准
- •Infection at the injection site
- •Coagulopathy
- •Spinal anomalies
- •Allergy to local anesthetics
- •Parental refusal.
研究组 & 干预措施
Group C (caudal block)
Group
干预措施: Caudal Block Anesthesia (Procedure)
Group S (sacral ESP block)
Cohort
干预措施: Erector Spinae Plane Block (Procedure)
结局指标
主要结局
The pain status of patients in both groups will be evaluated with the FLACC score at postoperative 1, 2, 4, 6, 12 and 24 hours.
时间窗: It will be evaluated at 1, 2, 4, 6, 12 and 24 hours postoperatively.
FLACC: Face, Leg, Activity, Cry, Consolability. The FLACC score is an observational pain assessment tool used primarily in pediatric patients who are unable to communicate verbally. It evaluates pain based on five behavioral categories: 'Face, Legs, Activity, Cry, and Consolability', each scored from 0 to 2, resulting in a total score ranging from 0 to 10. A score of 0 indicates no pain, while 1-3 reflects mild pain, 4-6 moderate pain, and 7-10 severe pain. Higher FLACC scores represent poorer pain control and greater patient discomfort, whereas lower scores suggest effective analgesia and adequate patient comfort. Elevated FLACC scores are clinically significant, as they are associated with increased stress responses, agitation, fluctuations in cardiopulmonary parameters, delayed mobilization, and prolonged recovery in pediatric patients.
次要结局
未报告次要终点
研究者
Sümeyye
Residents in Anesthesiology
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization