Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
Two methods of pain control in children undergoing surgery on the groin and scrotum are caudal injection (a form of epidural) with local anaesthetic, and a regional nerve block (an injection of local anaesthetic around the nerves supplying the area). A pilot study at our hospital showed a significant decrease in post-operative pain and nausea and vomiting in these two methods when compared to intravenous morphine and local anaesthetic to the wound.
One potential side effect from caudal injections is temporarily decreased motor power in the legs due to the local anaesthetic - it is thought that this might be overcome using a more dilute solution of local anaesthetic along with clonidine. This study is to demonstrate that this method is as effective as the use of a regional 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
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children undergoing day case elective inguinal-scrotal surgery
排除标准
- •Contraindication to technique
- •Significant comorbidities
- •Patient/parent refusal
研究组 & 干预措施
Caudal block
Caudal epidural given for post-operative pain relief. Dose used is 1.5ml/kg of weak Levo-Bupivacaine solution (0.125%).
Patients will also receive standardised pain relief of paracetamol and fentanyl
干预措施: Caudal block (Procedure)
Caudal block
Caudal epidural given for post-operative pain relief. Dose used is 1.5ml/kg of weak Levo-Bupivacaine solution (0.125%).
Patients will also receive standardised pain relief of paracetamol and fentanyl
干预措施: Standarising intraoperative pain relief (Drug)
Nerve block
Peripheral nerve block given for post operative pain relief. Levo-Bupivacaine 0.25% 2mg/Kg given under ultrasound guidance.
Patients will also receive standardised pain relief of paracetamol and fentanyl
干预措施: Nerve Block (Procedure)
Nerve block
Peripheral nerve block given for post operative pain relief. Levo-Bupivacaine 0.25% 2mg/Kg given under ultrasound guidance.
Patients will also receive standardised pain relief of paracetamol and fentanyl
干预措施: Standarising intraoperative pain relief (Drug)
结局指标
主要结局
Pain relief
时间窗: Discharge postoperatively (approximately 2-4 hours postoperatively)
VAS for verbal children
次要结局
- Motor paresis assessed with the Bromage score(Discharge postoperatively (approximately 2-4 hours postoperatively))
研究者
Dr Kumarvel Veerappan
Consultant Paediatric Anaesthatist
Medway NHS Foundation Trust