Perineural Dexmedetomidine Vs Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- time to the first need of opiate following the procedure
研究概览
简要总结
Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.
详细描述
This study is proposed to explore the effect of systemic Dexamethasone on the duration of popliteal block for analgesia after pediatric ankle surgery.
After ankle/foot surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
The safety of local anaesthesia is essential in children due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.
In this study, investigators compare perineural Dexmedetomidine and Dexamethasone. Group 2 will have Dexamethasone in a 0.1mg/kg dose, and group 2 will have dexmedetomidine in a 0.5 ug/kg dose added to the local anaesthetic in peripheral 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children scheduled for foot/ankle surgery
- •body weight > 5kg
排除标准
- •infection at the site of the regional blockade
- •coagulation disorders
- •immunodeficiency
- •ASA= or >4
- •steroid medication in regular use
研究组 & 干预措施
Sham Block
0.2% ropivacaine for popliteal nerve block
干预措施: 0.9% Sodium chloride (Drug)
Dexamethasone
0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block
干预措施: 0.1mg/kg Dexamethasone (Drug)
Dexmedetomidine
0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block
干预措施: 0.05ug/kg Dexmedetomidine (Drug)
结局指标
主要结局
time to the first need of opiate following the procedure
时间窗: within 48 hours
Time after surgery when the patient needs opiate for the first time
次要结局
- Platelet-to-lymphocyte ratio(24 hours after surgery)
- Time to mobilization(within 48 hours)
- Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale(48 hours)
- Neutrophil-to-lymphocyte ratio(24 hours after surgery)