Does Perineural Dexamethasone Prolong Duration of an Adductor Canal Block When Controlling for a Systemic Effect? A Paired, Randomized, Blinded, Study in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab
研究概览
简要总结
The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks.
The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists class 1
- •Body Mass Index 18-30
排除标准
- •Allergy to study medication
- •Earlier trauma or surgery to lower limb
- •Diabetes Mellitus
- •Alcohol or drug abuse
- •Daily intake of opioids or steroids last 4 weeks
- •Daily intake of any analgesics last 48 hours
研究组 & 干预措施
Ropivacaine + dexamethasone
20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml
干预措施: Ropivacaine + dexamethasone (Drug)
Ropivacaine + placebo
20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad
干预措施: Ropivacaine + placebo (Drug)
结局指标
主要结局
Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab
时间窗: 0-36 hours
Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0, except at 2 and 3 hours post block where there will be a break and no assessments will be performed.
次要结局
- Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold(0-36 hours)
- Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation(0-36 hours)
- Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick(0-36 hours)
- Difference between dexamethasone and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test(0-36 hours)
- Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold(0-36 hours)
研究者
Pia Jaeger
Coordinating Investigator
Rigshospitalet, Denmark