Popliteal Block for Postoperative Pain in Knee-ankle Soft Tissue Surgery in Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The number of fluctuations of skin conductance per second (NFSC).
研究概览
简要总结
Popliteal block is a technique for providing postoperative pain management in children. In this randomized double-blinded study, the investigators evaluated the effects of preoperative popliteal nerve block on postoperative pain and analgesic requirement in children with cerebral palsy (CP) undergoing knee-anckle soft tissue surgery. The Wong Baker faces scale and skin conductance fluctuations will be assessed.
详细描述
Sevoflurane will be used for anesthesia induction and maintance. Laryngeal mask airway will be placed without neuromuscular blocking agent. In group P (popliteal block), a single dose of 0.3ml.kg(-1) of 0.25% bupivacaine will be performed for popiteal nerve block (with ultrasound guidence). In group C ( control), only plaster cover will be applied without nerve block for sham procedure to provide double-blinded study. Intraoperative heart rate, mean arterial pressure, BIS (bispectral index) values, sevoflurane consumption will be recorded ten minutes interval. Wong Baker faces scale and skin conductance fluctuations will be recorded at postoperative 0, 10th min, 20th min , 1st h, 4th h, 12th h qnd 24th h. Total analgesic consumption (paracetamol orally ) will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with cerebral palsy
- •Scheduled for knee and ankle surgery
排除标准
- •Autonomic neuropathy
- •Medication with anticholinergic drugs
- •Continuous infusion of vasoactive drugs
研究组 & 干预措施
popliteal block
Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.
干预措施: Popliteal block (Procedure)
popliteal block
Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.
干预措施: Sevoflurane (Drug)
popliteal block
Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.
干预措施: Ultrasound (Device)
popliteal block
Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.
干预措施: bupivacaine (Drug)
popliteal block
Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.
干预措施: Laryngeal mask airway (Other)
Plaster cover
Only plaster cover will be applied without nerve block for sham procedure.
干预措施: Sevoflurane (Drug)
Plaster cover
Only plaster cover will be applied without nerve block for sham procedure.
干预措施: Plaster cover (Other)
Plaster cover
Only plaster cover will be applied without nerve block for sham procedure.
干预措施: Laryngeal mask airway (Other)
结局指标
主要结局
The number of fluctuations of skin conductance per second (NFSC).
时间窗: The patients will be followed up to 24 hours
Postoperative pain assessment via Wong Baker faces scale
时间窗: The patients will be followed up to 24 hours
次要结局
未报告次要终点
研究者
derya özkan
Associate Professor
Diskapi Teaching and Research Hospital