Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Hip Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 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 hip arthroplasty
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 hip arthroplasty
- •aged >18 years and <100 years
- •ASA physical status 1, 2 or 3.
排除标准
- •if they refused to participate,
- •had a history of opioid abuse,
- •had an infection of the site of needle puncture,
- •were less than 18 years of age,
- •were postponed as having ASA 4 or 5,
- •had an allergy to any of the drugs used in the study,
- •renal failure (estimated glomerular filtration rate <15ml/min/1.73m2),
- •liver failure,
- •known or suspected coagulopathy,
- •pre-existing anatomical or neurological disorders in the lower extremities,
- •intellectual disability with problems in pain evaluation,
- •severe psychiatric illness.
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 + 4mg Dexamethasone for erector spinae plane block
干预措施: Dexamethasone (Drug)
Dexmedetomidine
0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae 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 after surgery
Time after surgery when the patient needs opiate for the first time
次要结局
- NLR(48 hours after surgery)
- PLR(48 hours after surgery)
- Numerical Rating Scale [range 0:10](24 hours after surgery)
- Opioid consumption(48 hours after surgery)