Comparison of the Analgesic Effect of the Local Anesthetics Ropicacaine, Levobupivacaine, and Levobupivacaine + Epinephrin Via Interscalene Nerve Block in Patients Undergoing Shoulder Arthroscopy Under General Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Length of nerve block measured in longitudinally recorded significant changes in sensory thresholds using quantitative sensory testing
研究概览
简要总结
Several reports have compared the duration of action of levobupivacaine and ropivacaine as local anesthetic. The most widely used method for sensory function evaluation is though means of a pinprick test. The investigators want to use the novel method of Quantitative Sensory Testing to better evaluate the anesthetic activity. This method used hot and cold sensation to assess small nerve fiber function. The investigators will assess the duration of action of different drugs when used in an inter scalene nerve block in patients scheduled for shoulder surgery.
详细描述
This study aims to compare the length of the analgesic effect of different local anesthesic solutions, used in an interscalene nerve block. This will be objectified by measuring the changes in small nerve functioning, using quantative sensory testing. Based on the results of a previous study, the investigators reduce the dose of the administered local anesthetic, expecting a similar length of action using these smaller doses.
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
- •American Society of Anesthesia class I or II
- •Scheduled for shoulder surgery
排除标准
- •Mental retardation
- •Allergy for local anesthetics
- •NSAID intolerance or contraindicated
- •Diabetes mellitus
- •Chronic use of pain killers
研究组 & 干预措施
Ropivacaine 0.75%
The investigators administer 5 milliliters of Ropivacaine 0.75% in the inter scalene space
干预措施: Ropivacaine 0.75% (Drug)
Levobupivacaine 0.5%
The investigators administer 5ml of Levobupivacaine 0.5% in the inter scalene space
干预措施: Levobupivacaine 0.5% (Drug)
Levobupivacaine 0.5% + epinephrin
The investigators administer 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in the inter scalene space
干预措施: Levobupivacaine 0.5% + epinephrin 1/200000 (Drug)
结局指标
主要结局
Length of nerve block measured in longitudinally recorded significant changes in sensory thresholds using quantitative sensory testing
时间窗: 24 hours after intervention
Length of difference in cold and heat pain and sensation measured with quantitative sensory testing
次要结局
- Motor activity block, longitudinally recorded inability to move the blocked limb(24 hours after intervention)
- Need for rescue drugs, as requested by the patient after surgery(24 hours after intervention)
- Intensity of nerve block, recorded as maximal changes in sensory thresholds using quantitative sensory testing(24 hours after intervention)
研究者
Tom Schepens, MD
MD
University Hospital, Antwerp