Acute Nociceptive Pain, Allodynia, Hyperalgesia, Opioid-induced Hyperalgesia
Conditions
Keywords
Cannabidiol, Remifentanil
Brief summary
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).
Detailed description
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.
Interventions
DRUGCBD
1600mg cannabidiol, single oral dose (8 ml oily solution)
DRUGPlacebo
Placebo p.o, single oral dose (8 ml oily solution)
DRUGRemifentanil
Remifentanil 0.1 µg/kg/min i.v. for 30 min
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* BMI between 18.5 until 25 kg/m2 * Able to give informed consent
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hyperalgesia measured by the area under the curve (AUCHyper) | from minute 100 to minute 160 after termination of remifentanil infusion | Change in hyperalgesia measured by the area under the curve (AUCHyper) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain response (NRS) measured by the area under the curve (AUCNRS) | from minute 70 to minute 90 during remifentanil infusion | Change in pain response (NRS) measured by the area under the curve (AUCNRS) |
| Change in hyperalgesia measured by the area under the curve (AUCHyper) | from minute 70 to minute 90 during remifentanil infusion | Change in hyperalgesia measured by the area under the curve (AUCHyper) |
| Change in allodynia measured by the area under the curve (AUCAllo) | from minute 70 to minute 90 during remifentanil infusion | Change in allodynia measured by the area under the curve (AUCAllo) |
Countries
Switzerland
Outcome results
None listed