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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
21
1600mg cannabidiol, single oral dose (8 ml oily solution)
Placebo p.o, single oral dose (8 ml oily solution)
Remifentanil 0.1 µg/kg/min i.v. for 30 min
Department of Anaesthesiology, University Hospital of Basel (USB)
Basel, Switzerland
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Time frame: from minute 100 to minute 160 after termination of remifentanil infusion
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
Time frame: from minute 70 to minute 90 during remifentanil infusion
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Change in hyperalgesia measured by the area under the curve (AUCHyper)
Time frame: from minute 70 to minute 90 during remifentanil infusion
Change in allodynia measured by the area under the curve (AUCAllo)
Change in allodynia measured by the area under the curve (AUCAllo)
Time frame: from minute 70 to minute 90 during remifentanil infusion
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
Change in pain response (NRS) measured by the area under the curve (AUCNRS)
Time frame: from minute 100 to minute 160 after termination of remifentanil infusion
Change in allodynia measured by the area under the curve (AUCAllo)
Change in allodynia measured by the area under the curve (AUCAllo)
Time frame: from minute 100 to minute 160 after termination of remifentanil infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.