The Efficacy of Post-operative Analgesia of Sacral Erector Spinae Plane Block Versus Caudal Block in Penile Surgeries in Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Time to first rescue analgesic.
研究概览
简要总结
The study will be conducted to compare the efficacy of ultrasound guided Sacral Erector Spinae Plane Block to caudal block on pain management in penile surgeries in pediatrics.
详细描述
The erector spinae plane block (ESPB) is a relatively new interfacial plane block that is used for postoperative analgesia in penile surgeries in pediatrics.
The sacral ESPB is a technique known to block the posterior branches of the sacral nerves. Also it blocks the lumbosacral plexus especially the sacral spinal nerves (S2_S4) when applied to high levels.
Caudal epidural block in children is one of the most widely administrated technique of regional anesthesia; it is an efficient way to offer perioperative analgesia for painful sub umbilical interventions. It enables early ambulation, hemodynamic stability and spontaneous breathing in patient groups at maximum risk of difficult airway.
Caudal block is a known worldwide technique but with some risks such as subdural, intra vascular injection, infection, injury to the nerve root or local anesthesia. Therefore, we try a new technique as sacral ESPB.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Children aged between 3 to 6 years.
- •Male children.
- •American Society of Anesthesiologists (ASA) I - II.
- •Male who admitted for penile surgeries.
排除标准
- •Parents who refused regional anesthesia.
- •Patients presented with symptoms or signs of increased intracranial tension.
- •Patients presented with advanced kidney, cardiac or liver diseases.
- •Coagulation and bleeding disorders.
- •Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
- •Pre-existing neurologic disease (e.g. lower extremity peripheral neuropathy).
- •Patients with known allergy to study drugs.
- •Patints with developmental or mental delay.
研究组 & 干预措施
Caudal block
Patients were received (plain bupivacaine 0.25% 1 mg/kg + 2 % lidocaine 3 mg /kg) in total volume 1ml/ kg max 20 ml via Ultrasound Guided caudal Block.
干预措施: Caudal block (Procedure)
Sacral erector spinae
Patients were received (plain bupivacaine 0.25% 1 mg/kg + 2 % lidocaine 3 mg /kg) in total volume of 1 ml/ kg maximum 20ml divided in both sides via ultrasound guided sacral erector spinae plain block (ESPB).
干预措施: Sacral erector spinae block (Procedure)
结局指标
主要结局
Time to first rescue analgesic.
时间窗: 24 hours postoperatively
The time to first rescue analgesia was measured from the end to surgery till first dose of paracetamol administrated.
次要结局
- Total rescue analgesia consumption(24 hours postoperatively)
- The degree of pain(24 hours postoperatively)
研究者
Aya Allah Hamdy Elbahy
Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University