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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBD + Remifentanil | Active Comparator | CBD 1600 mg p.o. + Remifentanil 0.1 µg/kg/min i.v. for 30 min |
|
| Placebo + Remifentanil | Placebo Comparator | Placebo p.o + Remifentanil 0.1 µg/kg/min i.v. for 30 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD | Drug | 1600mg cannabidiol, single oral dose (8 ml oily solution) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hyperalgesia measured by the area under the curve (AUCHyper) | Change in hyperalgesia measured by the area under the curve (AUCHyper) | from minute 100 to minute 160 after termination of remifentanil infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | from minute 70 to minute 90 during remifentanil infusion |
| Change in hyperalgesia measured by the area under the curve (AUCHyper) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Schneider, MD | Department of Anaesthesiology, University Hospital of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, University Hospital of Basel (USB) | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35239547 | Derived | Dieterle M, Zurbriggen L, Mauermann E, Mercer-Chalmers-Bender K, Frei P, Ruppen W, Schneider T. Pain response to cannabidiol in opioid-induced hyperalgesia, acute nociceptive pain, and allodynia using a model mimicking acute pain in healthy adults in a randomized trial (CANAB II). Pain. 2022 Oct 1;163(10):1919-1928. doi: 10.1097/j.pain.0000000000002591. Epub 2022 Jan 24. |
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| Placebo |
| Drug |
Placebo p.o, single oral dose (8 ml oily solution) |
|
| Remifentanil | Drug | Remifentanil 0.1 µg/kg/min i.v. for 30 min |
|
Change in hyperalgesia measured by the area under the curve (AUCHyper) |
| 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) | 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) | 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) | from minute 100 to minute 160 after termination of remifentanil infusion |
| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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