The Effect of Dexamethasone Used Together With Low Volume Ropivacaine in a Single Shot Interscalene Block on the Pain Free Time Experienced by the Patient
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Pain free time measured by the duration between block and the point at which the patient is asking for painkillers
研究概览
简要总结
The main aim of the study is to investigate the proven effect of dexamethsone on the duration of the interscalene block. The investigators try to define optimal dose and volume for ropivacaine, when used together with dexamethsone. The current literature uses often very high volumes of ropivacain when used together with dexamethasone. The investigators try to research the effect of using dexamethsone together with low volume, high concentration ropivacaine for interscalene blockade. The investigators' hypothesis is that dexamethasone has an positive effect on the pain free after used together with ropivacaine at the scalene 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
- Triple (Participant, Care Provider, Investigator)
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
- •atroscopy of the shoulder
- •repair of the RM
排除标准
- •patient under 18 years
- •patient is fertile
- •chronic opiat use more than 30mg oxycodone per day
- •operations at the shoulder that involves the bone
- •usage of cortisone for more than 2 weeks
- •risk greater as asa III
- •damage to nerves
- •neuropathy at the target arm
研究组 & 干预措施
Verum
Dexamethasone and Ropivacaine
干预措施: Dexamethasone acetate (Drug)
Verum
Dexamethasone and Ropivacaine
干预措施: Ropivacaine (Drug)
Placebo
Ropivacaine and Saline
干预措施: Placebo (Drug)
Placebo
Ropivacaine and Saline
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Pain free time measured by the duration between block and the point at which the patient is asking for painkillers
时间窗: Patients will be followed during their stay at the hospital, which will be normally around 24 to 48 hours.
次要结局
- Visual Rating Scale for Pain at Movement and Rest(Measured 10 hours after the intervention)