Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine 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 perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine 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 spine surgery.
After spine surgery, patients 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 due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, 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 and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae Plane Block.
In this study, investigators compare perineural Dexamethasone and Dexmedetomidine.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing primary posterior lumbar decompression and stabilization with instrumentation involving multi-levels in the lumbar region,
- •aged >18 years and <100 years
- •ASA physical status 1, 2 or 3.
排除标准
- •refuse to participate,
- •history of opioid abuse,
- •infection of the puncture site,
- •aged <18 years and >100 years
- •ASA 4 and 5
研究组 & 干预措施
placebo
0.2% ropivacaine for erector spinae plane block
干预措施: 0.9% Sodium Chloride Injection (Drug)
Dexamethasone
0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block
干预措施: Dexamethasone 4 Mg/mL Injectable Solution (Drug)
Dexmedetomidine
0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block
干预措施: Dexmedetomidine injection (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](Time Frame: 24 hours after surgery)
- NLR(48 hours after surgery)
- PLR(48 hours after surgery)