NCT02879916已完成4 期
Comparison of the Analgesic Effect of Levobupivacaine 0.5% Via Interscalene Nerve Block or Via Interscalene Nerve Block Combined With a Stellate Ganglion Block in Patients Undergoing Shoulder Arthroscopy With General Anaesthesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Duration of analgesia
研究概览
简要总结
This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Half of the recruited patients will receive a stellate ganglion block and half of the patients won't.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA class 1 to 3
- •Need for shoulder surgery
排除标准
- •Mental retardation
- •allergy for local anesthetics
- •a medical reason as a contra-indication for NSAID use
- •Diabetes mellitus
- •peripheral neuropathy
- •chronic analgetic use
- •chronic pain patients
研究组 & 干预措施
Placebo
Placebo Comparator
NaCl 0.9% 3ml perineural stellate ganglion injection
干预措施: NaCl 0.9% (Drug)
Stellate ganglion block
Active Comparator
Levobupivacaine 3ml perineural stellate ganglion injection
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
Duration of analgesia
时间窗: 24 hours
The duration of analgesia assessed with quantitative sensory testing
次要结局
- Need for rescue analgesia(24 hours)
- Duration of motor block(24 hours)
研究者
Tom Schepens, MD
research assistant
University Hospital, Antwerp
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