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临床试验/NCT07619651
NCT07619651招募中不适用

Prospective Comparison of Sacral Erector Spinae Plane Block and Caudal Epidural Block for Postoperative Analgesia in Pediatric Hypospadias Surgery

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Postoperative Pain Score Assessed by FLACC Scale

研究概览

简要总结

Hypospadias surgery in pediatric patients requires effective postoperative analgesia to ensure patient comfort and reduce perioperative stress. Caudal epidural block is widely used for analgesia in pediatric urological procedures; however, alternative regional techniques such as the sacral erector spinae plane (ESP) block have recently gained attention.

This prospective comparative study aims to compare the analgesic efficacy of sacral ESP block and caudal epidural block in pediatric patients undergoing hypospadias surgery. Participants will be allocated to receive either sacral ESP block or caudal epidural block according to the study protocol.

The primary outcome will be postoperative pain scores within the first 24 hours after surgery. Secondary outcomes will include total analgesic consumption, time to first rescue analgesia, and block-related complications.

详细描述

Hypospadias is one of the most common congenital urogenital anomalies in pediatric patients and typically requires surgical correction in early childhood. Effective postoperative pain management is essential to improve patient comfort, reduce perioperative stress, and prevent complications. Inadequate pain control in pediatric surgical patients has been associated with increased morbidity, prolonged hospital stay, and delayed recovery.

Caudal epidural block is widely used for postoperative analgesia in pediatric urological surgery due to its ease of application and high success rate. However, it has limitations such as relatively short duration of analgesia and potential side effects including motor block, urinary retention, and lower extremity weakness. Therefore, alternative regional anesthesia techniques that may provide longer-lasting analgesia with fewer side effects are of increasing interest.

The erector spinae plane (ESP) block is a relatively novel regional anesthesia technique that provides both somatic and visceral analgesia and can be applied at different spinal levels. The sacral approach to ESP block has recently been described as a potential alternative for lower abdominal and urogenital surgeries. However, evidence regarding its effectiveness in pediatric hypospadias surgery remains limited.

This prospective comparative study aims to compare the analgesic efficacy, postoperative analgesic requirements, and block-related complications of sacral erector spinae plane block and caudal epidural block in pediatric patients undergoing hypospadias repair surgery.

Patients aged between 6 months and 7 years with ASA physical status I-II scheduled for hypospadias repair will be included. Participants will be allocated into either the sacral ESP block group or the caudal epidural block group according to the study protocol.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 7 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Male patients aged between 6 months to 7 years
  • Scheduled for hypospadias repair surgery
  • ASA physical status I-II
  • No known allergy to local anesthetic agents
  • No contraindications to peripheral nerve blocks
  • Written informed consent obtained from parents or legal guardians

排除标准

  • Known congenital coagulopathy
  • Known allergy to local anesthetic agents
  • Severe systemic disease (ASA III-IV)
  • Severe organ failure
  • Neurological disorders

研究组 & 干预措施

Sacral ESP Block Group

Experimental

Patients receiving ultrasound-guided sacral erector spinae plane block for postoperative analgesia

干预措施: Sacral ESP Block (Procedure)

Caudal Epidural Block Group

Active Comparator

Patients receiving caudal epidural block for postoperative analgesia

干预措施: Caudal Epidural Block (Procedure)

结局指标

主要结局

Postoperative Pain Score Assessed by FLACC Scale

时间窗: Within the first 24 hours after surgery

Postoperative pain intensity will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale in pediatric patients undergoing hypospadias repair surgery. The FLACC scale consists of five behavioral categories (Face, Legs, Activity, Cry, Consolability), each scored from 0 to 2 points, resulting in a total score ranging from 0 to 10. Higher scores indicate greater pain intensity. FLACC scores will be recorded at 30 minutes, and at 1, 4, 12, and 24 hours after surgery. Rescue analgesia will be administered when the FLACC score is 4 or greater.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem ÖZ GERGİN

Principal Investigator

TC Erciyes University

研究点 (1)

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