Does Perineural Dexmedetomidine Prolong Duration of a Nerve Block?
Does Perineural Dexmedetomidine Prolong the Duration of an Adductor Canal Block When Controlling for a Systemic Effect? - A Randomised Paired Trial in Healthy Volunteers.
研究概览
详细说明
Background:
Efficient pain management promoting mobilization and convalescence is essential in an ideal perioperative course. Regional nerve blocks are a central element in postoperative regimes for many patients and it is therefore important that these nerve blocks are both long lasting and efficient. This trial will investigate whether it is possible to optimize the postoperative pain management when adding dexmedetomidine to the local anaesthetic ropivacaine in peripheral nerve blocks.
The prolonging effect of using dexmedetomidine as adjunct in peripheral nerve blocks have been investigated in several studies. However, it remains uncertain whether the effect is mediated by a systemic-, a peripheral- or a combined systemic/peripheral mechanism. In this trial the adjuvating effect of dexmedetomidine will be investigated using the adductor canal block. This is a nerve block that besides being efficient as pain treatment after knee surgery, is primarily sensory, and therefore augments mobilization after total knee arthroplasty.
Method:
On the trial day the volunteers will receive bilateral adductor canal blocks. In one thigh they will receive the local anaesthetic ropivacaine 20ml 5mg/ml and placebo (saline) and in the other thigh ropivacaine 20ml 5mg/ml and dexmedetomidine 100μg. The allocation is blinded to volunteer and investigator.
The duration of the nerve block will be measured by five different tests: Temperature test, Pinprick, Pain during tonic heat stimulation, Warmth detection threshold and pain detection threshold. All tests are validated within pain research.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Koege、丹麦、4600
- Department of Anesthesiology Koege Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- American Society of Anesthesiologists class 1
- Body Mass Index 18-30
Exclusion Criteria:
- 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 Heart block Sick sinus node.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Ropivacaine + Dexmedetomidine
Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Dexmedetomidine 100ug/ml
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100 ug dexmedetomidine added to the ropivacaine nerveblock
其他名称：
20 ml Ropivacaine 5mg/ml
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安慰剂比较：Ropivacaine + Placebo
Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Saline
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20 ml Ropivacaine 5mg/ml
Placebo
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference in duration of sensory block between dexmedetomidine and placebo assessed as cold sensation with an alcohol swab
大体时间：0-36 hours
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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) Time for sleep will be provided.
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0-36 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed by pin-prick
大体时间：0-36 hours
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Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided.
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0-36 hours
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test
大体时间：0-36 hours
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Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block.Time for sleep will be provided.
Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value.
A Linear 100mm visual analogue scale (VAS) will be used.
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0-36 hours
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as warmth detection threshold
大体时间：0-36 hours
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Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided.
Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
Time for sleep will be provided
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0-36 hours
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as heat pain detection threshold
大体时间：0-36 hours
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Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block.
Time for sleep will be provided.
Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
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0-36 hours
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Difference in maximum pain scores between dexmedetomidine and placebo during block and after recovery of normal sensation.
大体时间：0-36 hours
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Pain scores during a tonic heat stimulation will be compared every hour post block and 1 h after pain scores have returned to the pre-block values.
Time for sleep will be provided.
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0-36 hours
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合作者和调查者
调查人员
- 首席研究员：Jakob H Andersen, MD、Department of Anesthesiology Koege Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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