Determination of the Minimal Effective Concentration (EC90) of Ropivacaine in Axillary Brachial Plexus Block With Intravenous Dexamethasone or Saline Injection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Surgical Effectiveness of regional anesthesia at 30min
研究概览
简要总结
Prospective up and down sequential evaluation of the minimal effective concentration of perineural ropivacaine for 90% success in axillary brachial plexus block with the injection of intravenous dexamethasone or saline placebo during regional anesthesia performance
详细描述
ropivacaine concentration determined by up and down sequential method dexamethasone or saline placebo determined by randomisation
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
- •18 years old or older
- •ASA Score 1,2 et 3 (American Society of Anesthesiologists Score)
- •surgery under axillary brachial plexus block
- •signed information consent
排除标准
- •pregnancy and breastfeeding
- •contraindication to regional anesthesia or technical impossibility
- •impaired coagulation
- •delay of surgery to short to allow regional anesthesia
- •dementia or under administrative supervision
- •allergy and contraindication to dexamethasone or ropivacaine
- •total dose of ropivacaine higher than 3 mg / kg (recommended dose for upper limb regional anesthesia)
- •opioids or pain killers abuse or addiction
- •steroids consumption in the past 6 months
- •surgery estimated to be greater than 4 hours
- •anticipated bad observation of treatment
- •patient enrolled in another trial
研究组 & 干预措施
Intravenous dexamethasone
Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method.
Intravenous injection of 8mg/2ml Dexamethasone during the regional anesthesia
干预措施: Intravenous dexamethasone (Drug)
Intravenous dexamethasone
Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method.
Intravenous injection of 8mg/2ml Dexamethasone during the regional anesthesia
干预措施: Perineural ropivacaine (Drug)
Intravenous saline
Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method.
Intravenous injection of 2ml Saline 0.9% during the regional anesthesia
干预措施: Intravenous saline (Drug)
Intravenous saline
Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method.
Intravenous injection of 2ml Saline 0.9% during the regional anesthesia
干预措施: Perineural ropivacaine (Drug)
结局指标
主要结局
Surgical Effectiveness of regional anesthesia at 30min
时间窗: Time of surgery
Ability to perform surgery under regional anaesthesia without supplementary anaesthesia
次要结局
- time between regional anesthesia and surgical incision(Time of surgery)
- Effectiveness of regional anaesthesia on motor function(Time of anaesthesia)
- recovery of regional anesthesia: pain(first 48h)
- complication related to regional anesthesia and/or intravenous dexamethasone(month 6)
- Effectiveness of regional anaesthesia on Pin-Prick sense(Time of anaesthesia)
- Effectiveness of regional anaesthesia on cold sensation(Time of anaesthesia)
- recovery of regional anesthesia: motor(first 48h)
- recovery of regional anesthesia: sensory(first 48h)