Does Perineural Dexmedetomidine Prolong the Duration of an Ulnar Nerve Block When Controlling for Possible Systemic Effects?
试验速览
- 阶段
- 2 期
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and placebo
研究概览
简要总结
The aim of this trial is to investigate if dexmedetomidine prolongs the duration of an ulnar nerve block. By using healthy volunteers the investigators can perform bilateral ulnar nerve blocks and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. The investigators hypothesis is that 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 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 an ulnar nerve block.
Method:
The participants will attend two trial days.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must understand the protocol fully and sign the written in-formed consent.
- •BMI > 18 to < 30
- •For fertile women: safe contraceptives for the last month and a nega-tive urin HCG.
排除标准
- •Participants unable to cooperate in the trial.
- •Participants unable to speak or read Danish
- •Allergy to study medication.
- •Alcohol consumption >21 units for men and >14 for women per week
- •Daily intake of prescription painkillers within the last 4 weeks.
- •Over the counter painkillers during the last 48 hours.
- •Neuromuscular defects or wounds on the arms or hands preventing test performance.
- •Diabetes Mellitus
- •degree heart block
- •Sick sinus node.
- •For fertile women a positive urine HCG
研究组 & 干预措施
Perineural dexmedetomidine
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml 100ug/ml dexmedetomidine perineurally
干预措施: Dexmedetomidine perineurally (Drug)
Perineural dexmedetomidine
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml 100ug/ml dexmedetomidine perineurally
干预措施: Ropivacaine 5mg/ml (Drug)
Systemic dexmedetomidine
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally + 100ug dexmedetomidine systemically (absorbed and redistributed from the opposite ulnar nerve block)
干预措施: Ropivacaine 5mg/ml (Drug)
Systemic dexmedetomidine
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally + 100ug dexmedetomidine systemically (absorbed and redistributed from the opposite ulnar nerve block)
干预措施: Dexmedetomidine systemically (Drug)
Systemic dexmedetomidine
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally + 100ug dexmedetomidine systemically (absorbed and redistributed from the opposite ulnar nerve block)
干预措施: Isotonic saline (Drug)
Placebo
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally
干预措施: Ropivacaine 5mg/ml (Drug)
Placebo
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally
干预措施: Isotonic saline (Drug)
High dose Ropivacaine
Ulnar nerve block 4ml ropivacaine 7.5mg/ml + 1ml isotonic saline (placebo) perineurally
干预措施: Ropivacaine 7.5mg/ml (Drug)
High dose Ropivacaine
Ulnar nerve block 4ml ropivacaine 7.5mg/ml + 1ml isotonic saline (placebo) perineurally
干预措施: Isotonic saline (Drug)
结局指标
主要结局
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and placebo
时间窗: 0-36 hours
Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and placebo
时间窗: 0-36 hours
Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and perineural dexmedetomidine
时间窗: 0-36 hours
Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.
次要结局
- Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between systemic dexmedetomidine and perineural dexmedetomidine(0-36 hours)
- Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between high dose ropivacaine and placebo(0-36 hours)
- Difference in duration of sensory nerve block assessed by temperature discrimination between perineural dexmedetomidine and placebo(0-36 hours)
- Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between systemic dexmedetomidine and placebo(0-36 hours)
- Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between perineural dexmedetomidine and systemic dexmedetomidine(0-36 hours)
- Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between high dose ropivacaine and placebo(0-36 hours)
- Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between perineural dexmedetomidine and placebo(0-36 hours)
- Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between systemic dexmedetomidine and placebo(0-36 hours)
- Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between high dose ropivacaine and placebo(0-36 hours)
- Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and placebo(0-36 hours)
- Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and placebo(0-36 hours)
- Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and systemic dexmedetomidine(0-36 hours)
- Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between high dose ropivacaine and placebo(0-36 hours)
- Difference in duration of sensory nerve block assessed by temperature discrimination between systemic dexmedetomidine and placebo(0-36 hours)
- Difference in duration of sensory nerve block assessed by temperature discrimination between systemic dexmedetomidine and perineural dexmedetomidine(0-36 hours)
- Difference in duration of sensory nerve block assessed by temperature discrimination between high dose ropivacaine and placebo(0-36 hours)
- Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between perineural dexmedetomidine and placebo(0-36 hours)
研究者
Jakob Hessel Andersen
Anesthesiologist, Staff Specialist
Zealand University Hospital