Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- first need of opiate
研究概览
简要总结
Effect of systematic dexamethasone on the duration of popliteal nerve block 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 nerve block for analgesia after pediatric ankle surgery.
After ankle or 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 anesthesia is particularly important in children due to the much lower toxicity threshold of local anesthetics. The use of an effective adjuvant, such as Dexamethasone, could allow for the use of a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.
There is multiple research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a huge lack of research regarding children.
In this study, investigators compare different doses of systemic dexamethasone. Before the anesthesia, the patients receive dexamethasone intravenously. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg, and 0.2mg/kg.
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
- Triple (Participant, Care Provider, Investigator)
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
- 是
入选标准
- •children scheduled for ankle/foot 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
placebo injection
5ml of 0,9% sodium chloride - before the popliteal nerve block
干预措施: Sodium Chloride 0.9% Inj (Drug)
0,1mg/kg Dexamethasone
0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
干预措施: 0,1mg/kg Dexamethasone (Drug)
0,2mg/kg Dexamethasone
0,2mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
干预措施: 0,2mg/kg Dexamethasone (Drug)
结局指标
主要结局
first need of opiate
时间窗: 48 hours
Time after surgery when the patient needs opiate for the first time
次要结局
- Opioid Consumption(48 hours)
- Pain score(4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery)
- Blood glucose(24 and 48 hours after surgery)
- NLR(24 and 48 hours after surgery)
- PLR(24 and 48 hours after surgery)
- Mobilisation(4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery)