A Comparison of the Efficacy of Sacral Erector Spinae Plane Block and Penile Block in Circumcision Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 主要终点
- FLACC Pain Score
研究概览
简要总结
Effective perioperative analgesia is crucial for reducing hospital stay in pediatric surgical patients. Opioid-based analgesia, although effective, may lead to respiratory depression in the postoperative period. Therefore, alternative regional anesthesia techniques such as penile block and sacral ESPB are increasingly preferred.
Sacral ESPB provides both somatic and visceral analgesia by blocking the dorsal and ventral rami of the spinal nerves. It has the potential to block the pudendal nerve and achieve bilateral effect with a single midline injection. However, comparative data between sacral ESPB and penile block in circumcision surgeries is limited.
详细描述
Effective perioperative analgesia is crucial for reducing hospital stay in pediatric surgical patients. Opioid-based analgesia, although effective, may lead to respiratory depression in the postoperative period. Therefore, alternative regional anesthesia techniques such as penile block and sacral ESPB are increasingly preferred.
Sacral ESPB provides both somatic and visceral analgesia by blocking the dorsal and ventral rami of the spinal nerves. It has the potential to block the pudendal nerve and achieve bilateral effect with a single midline injection. However, comparative data between sacral ESPB and penile block in circumcision surgeries is limited.
In this prospective, double-blind, randomized controlled trial, 62 children aged 2 to 7 years undergoing elective circumcision at the Department of Pediatric Surgery of Diyarbakır Gazi Yaşargil Training and Research Hospital will be randomly assigned to two groups:
Group I will receive sacral ESPB using 0.8 mL/kg of 0.25% bupivacaine
Group II will receive a penile block using the same dosage and concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I pediatric patients aged 2-7 years
- •Scheduled for elective circumcision
- •Informed consent obtained from parents/legal guardians
排除标准
- •ASA score other than I
- •Age <2 or >7 years
- •Known allergy to local anesthetics
- •Refusal to participate
研究组 & 干预措施
Group I - Sacral ESPB
Type: Procedure
Name: Sacral Erector Spinae Plane Block
Description: Ultrasound-guided sacral ESPB using 0.8 mL/kg of 0.25% bupivacaine
干预措施: 0.8 mL/kg of 0.25% bupivacaine (Drug)
Group II - Penile Block
Type: Procedure
Name: Penile Block
penile block using 0.8 mL/kg of 0.25% bupivacaine
干预措施: 0.8 mL/kg of 0.25% bupivacaine (Drug)
结局指标
主要结局
FLACC Pain Score
时间窗: From arrival in the recovery room until 24 hours postoperatively
Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 0, 15, 30, 45, 60, 90 minutes, and 2, 4, 6, 8, 10, 12, 18, and 24 hours after surgery. A FLACC score ≥4 will be treated with rescue analgesia.
次要结局
- Total Perioperative Opioid and Rescue Analgesic Consumption(Up to 24 hours postoperatively)
研究者
ali kendal oğuz
specialist doctor in anestesiology and reanimation
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital