Pain Response to Cannabidiol in Opioid-induced Hyperalgesia, Acute Nociceptive Pain and Allodynia By Using a Model Mimicking Acute Pain in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in hyperalgesia measured by the area under the curve (AUCHyper)
研究概览
简要总结
Prospective, randomized, placebo-controlled, double-blinded, crossover study to investigate the effect of cannabidiol (CBD) on remifentanil-induced hyperalgesia in healthy volunteers in a well-established acute pain model. Participants are randomized according to the order of the two treatments (CBD + Remifentanil or Placebo + Remifentanil).
详细描述
Opioid-induced hyperalgesia (OIH) is a clinically often neglected, but well described phenomenon. OIH could also be shown for Remifentanil in an acute pain model. As CBD showed antihyperalgesic potential in the animal model, this brings up the question if CBD might be used to prevent or diminish OIH. Until today there are no studies investigating CBD as an adjunct to remifentanil or other opioids regarding the OIH. This is however of great clinical value because CBD with its possible antihyperalgesic effect on the OIH might be a worthful adjunct for opioid based anaesthesia and analgesia.
Every participant will pass through two interventions with electrically induced pain (Koppert model). CBD will be applied orally at the beginning of the intervention. Pain, allodynia and hyperalgesia will be assessed and recorded every 10 min during the remifentanil infusion and afterwards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •BMI between 18.5 until 25 kg/m2
- •Able to give informed consent
排除标准
- •Regular consumption of cannabinoids or other drugs / substances
- •Regular intake of medications potentially interfering with pain sensation (analgesics, antihistamines, calcium and potassium channel blockers, serotonin / noradrenaline reuptake inhibitors, corticosteroids)
- •Neuropathy
- •Chronic pain
- •Neuromuscular disease
- •Psychiatric disease
- •Known or suspected kidney or liver disease
- •Pregnancy (cf. 8.6 Trial specific preventive measures) / Lactation
- •Allergy / hypersensitivity to cannabidiol
- •Contraindications for Remifentanil (e.g. hypersensitivity)
研究组 & 干预措施
CBD + Remifentanil
CBD 1600 mg p.o. + Remifentanil 0.1 µg/kg/min i.v. for 30 min
干预措施: CBD (Drug)
CBD + Remifentanil
CBD 1600 mg p.o. + Remifentanil 0.1 µg/kg/min i.v. for 30 min
干预措施: Remifentanil (Drug)
Placebo + Remifentanil
Placebo p.o + Remifentanil 0.1 µg/kg/min i.v. for 30 min
干预措施: Placebo (Drug)
Placebo + Remifentanil
Placebo p.o + Remifentanil 0.1 µg/kg/min i.v. for 30 min
干预措施: Remifentanil (Drug)
结局指标
主要结局
Change in hyperalgesia measured by the area under the curve (AUCHyper)
时间窗: from minute 100 to minute 160 after termination of remifentanil infusion
Change in hyperalgesia measured by the area under the curve (AUCHyper)
次要结局
- Change in hyperalgesia measured by the area under the curve (AUCHyper)(from minute 70 to minute 90 during remifentanil infusion)
- Change in pain response (NRS) measured by the area under the curve (AUCNRS)(from minute 100 to minute 160 after termination of remifentanil infusion)
- Change in allodynia measured by the area under the curve (AUCAllo)(from minute 100 to minute 160 after termination of remifentanil infusion)