Dexamethasone vs. Dexmedetomidine for Erector Spine Plane Block in Pain Management After Pediatric Idiopathic Scoliosis 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
- 1
- 主要终点
- first need of opiate
研究概览
简要总结
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.
详细描述
This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.
After scoliosis 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 essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use has been compared in adults. However, there is a massive lack of research regarding children.
In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children scheduled for idiopathic scoliosis surgery
- •age >10 and <18 years
排除标准
- •age < 10 years
- •age < 18 years
- •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
0.2% ropivacaine for erector spinae plane block
干预措施: 0.9% sodium chloride (Drug)
Dexamethasone
0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block
干预措施: Dexamethasone (Drug)
Dexmedetomidine
0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for erector spinal plane block
干预措施: Dexmedetomidine (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)
- Numerical Rating Scale [range 0:10](24 hours after surgery)
- NLR(24 and 48 hours after surgery)
- PLR(24 and 48 hours after surgery])
- MEP(durring surgery)
- Nerve damage [range 0-4](48 hours after surgery)
- adverce effects(48 hours after surgery)