Effects of Local Anaesthetic Infusion Rates on Nerve Block Duration. A Randomised, Blinded, Healthy Volunteer Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of insensitivity towards cold
研究概览
简要总结
This trial is a part of the project: 'A novel technique for reliable, precise and safe postoperative pain management' (project no. 65-2014-3).
The purpose of the trial is to investigate the effects of changing peri-neural infusion rates of ropivacaine 0.2% on the duration of nerve block.
Intervention:
Two intervention-days. Each day a peri-neural infusion of a fixed volume of ropivacaine 0.2% is to be infused in one of five infusion rates, using a peri-neural catheter.
Intervention day 1: Focus on the common peroneal nerve. Intervention day 2: Focus on the sciatic nerve.
详细描述
This trial is a part of the project: 'A novel technique for reliable, precise and safe postoperative pain management' (project no. 65-2014-3). Results will contribute to the development of an electrical disposable infusion pump manufactured by Ferrosan Medical Devices (FEMD). It is made up of two half's; first intervening day focuses on the common peroneal nerve, second intervening day focuses on the sciatic nerve.
Hypothesis:
The infusion rate of a single peri-neural injection of LA does not influence the duration of lower limb nerve blocks.
Trial objective:
We wish to compare five peri-neural infusion rates of LA as an independent factor of the duration of the nerve block, in the sciatic nerve and the common peroneal nerve, in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Infusion group 1
Intervention:
One peri-neural infusion of a fixed volume of ropivacaine 0.2%, administered via a perineurial nerve catheter.
Infusion rate will be 12 mL/h. This infusion rate is normal clinical practice when administering a perineural infusion of ropivacaine.
干预措施: Varying infusion rates of Ropivacaine 0.2% (Drug)
Infusion group 2
Intervention:
One peri-neural infusion of a fixed volume of ropivacaine 0.2%, administered via a perineurial nerve catheter.
Infusion rate will be 60 mL/h. This infusion rate is experimental.
干预措施: Varying infusion rates of Ropivacaine 0.2% (Drug)
Infusion group 3
Intervention:
One peri-neural infusion of a fixed volume of ropivacaine 0.2%, administered via a perineurial nerve catheter.
Infusion rate will be 300 mL/h. This infusion rate is experimental.
干预措施: Varying infusion rates of Ropivacaine 0.2% (Drug)
Infusion group 4
Intervention:
One peri-neural infusion of a fixed volume of ropivacaine 0.2%, administered via a perineurial nerve catheter.
Infusion rate will be 600 mL/h. This infusion rate is experimental.
干预措施: Varying infusion rates of Ropivacaine 0.2% (Drug)
Infusion group 5
Intervention:
One peri-neural infusion of a fixed volume of ropivacaine 0.2%, administered via a perineurial nerve catheter.
Infusion rate will be 1800 mL/h. This infusion rate is normal clinical practice when administering a perineural bolus of ropivacaine.
干预措施: Varying infusion rates of Ropivacaine 0.2% (Drug)
结局指标
主要结局
Duration of insensitivity towards cold
时间窗: Until nerve block remission (expected to be less than 24 hours).
Measuring insensitivity towards cold using cutaneous application of a round, cooled glass container, stored in a refrigerator (5°C). The time of normal sensation is subtracted the time of onset. This non-invasive measurement is a well-established way to evaluate the presumed anaesthetic effect of LA. It will be performed in the cutaneous innervation of the common peroneal nerve and the sciatic nerve accordingly. It will be measured in hours.
次要结局
- Length of neural exposure to ropivacaine(During drug administration, no longer than 150 minutes.)
- Degree of motor nerve block(Until nerve block remission (expected to be less than 24 hours).)
- Time to onset of sensory nerve block(From start of infusion until onset of sensory nerve block or for no more than three hours)