Does Perineural Clonidine Prolong the Duration of an Adductor Canal Block When Controlling for a Systemic Effect? - A Randomised Paired Trial in Healthy Volunteers.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Difference in duration of sensory block between clonidine and placebo assessed as cold sensation with an alcohol swab
研究概览
简要总结
The aim of this trial is to investigate if clonidine prolongs the duration of an adductor canal block. By using healthy volunteers the investigators can perform a bilateral adductor canal block and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. The investigators hypothesis is that clonidine/dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a peripheral mechanism.
详细描述
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 clonidine to the local anaesthetic ropivacaine in peripheral nerve blocks.
The prolonging effect of using clonidine as adjuncts 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 clonidine 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 Clonidine 150μg. The allocation is blinded to volunteer and investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists class 1
- •Body Mass Index 18-30
排除标准
- •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.
研究组 & 干预措施
Ropivacaine+Clonidine
Adductor Canal Block Ropivacaine 20ml 5mg/ml+ Clonidine 150ug
干预措施: Ropivacaine 20ml 5mg/ml+ Clonidine 150ug (Drug)
Ropivacaine+Placebo
Adductor Canal Block Ropivacaine 20ml 5mg/ml+ saline
干预措施: Ropivacaine 20ml 5mg/ml+ Placebo (Drug)
结局指标
主要结局
Difference in duration of sensory block between clonidine and placebo assessed as cold sensation with an alcohol swab
时间窗: 0-36 hours
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.
次要结局
- Difference between clonidine and placebo in the duration of a sensory block assessed as heat pain detection threshold(0-36 hour)
- Difference between Clonidine and placebo in the duration of a sensory block assessed by pin-prick(0-36 hours)
- Difference between clonidine and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test(0-36 hours)
- Difference between clonidine and placebo in the duration of a sensory block assessed as warmth detection threshold(0-36 hours)
- Difference in maximum pain scores between clonidine and placebo during block and after recovery of normal sensation.(0-36 hours)
研究者
Jakob Hessel Andersen
Anesthesiologist, Staff specialist
Zealand University Hospital