Intravenous Dexamethasone Versus Placebo for Ultrasound Guided Axillary Brachial Plexus Block With Ropivacaine: Randomised, Controlled, Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Analgesia duration after axillary brachial plexus block
研究概览
简要总结
Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after ultrasound guided axillary brachial plexus 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1,2 et 3
- •surgery under axillary brachial plexus block
- •aged >18 years
- •signed information consent
排除标准
- •impaired coagulation
- •contraindication to regional anesthesia or technical impossibility
- •opioids or pain killers abuse or addiction
- •steroids consumption in the past 6 months
- •dementia or under administrative supervision
- •delay of surgery to short to allow regional anesthesia
- •pregnancy and breastfeeding
- •allergy and contraindication to dexamethasone or ropivacaine
- •anticipated bad observation of treatment
- •patient enrolled in another trial
研究组 & 干预措施
intravenous dexamethasone
intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia
干预措施: intravenous dexamethasone (Drug)
intravenous dexamethasone
intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia
干预措施: perineural ropivacaine (Drug)
intravenous dexamethasone
intravenous injection of 8mg (2ml) of dexamethasone during regional anesthesia
干预措施: ultrasound guidance (Other)
intravenous placebo
intravenous injection of 2ml of NaCl 0.9% during regional anesthesia
干预措施: intravenous placebo (Drug)
intravenous placebo
intravenous injection of 2ml of NaCl 0.9% during regional anesthesia
干预措施: perineural ropivacaine (Drug)
intravenous placebo
intravenous injection of 2ml of NaCl 0.9% during regional anesthesia
干预措施: ultrasound guidance (Other)
结局指标
主要结局
Analgesia duration after axillary brachial plexus block
时间窗: time to first pain at surgical site, an average of 24 hours
次要结局
- Motor block duration after axillary brachial plexus block Safety(up to block recovery, an average of 24 hours)
- Sensory block duration after axillary brachial plexus block(up to block recovery, an average of 24 hours)
- incidence of adverse event(6 month)