About this trial
Clinical evidence about the effects of cannabis in the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute pain, at least for a selected group of patients and through an appropriate therapeutic intervention.
Cannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. And will help treat acute radicular back pain and for renal colic.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 - 70 years
ASA 1 or 2
Acute Radicular Pain < 12 weeks
Pain of VAS 6 or more/ VRS moderate or more
Disqualifiers
Age < 18 or > 70 years
ASA 3 or more
Chronic radicular pain > 12 weeks
Past spine surgery
Trial design
Sequential
Treatments tested in this trial
Single-dose of cannabis oil
DrugSingle-dose of cannabis oil in order to treat acute radicular pain
Control
DrugGiving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil
Treatment groups
Trial outcomes
Primary outcomes
opioid consumption via - Patient controlled administration (PCA)
Count of patient-controlled analgesia pushes.
Secondary outcomes
Nausea and vomiting (PONV) score
PONV score (0 - 4). Before administering baseline, after 0.5, 1, 2, 4, 8 12, 18, 24 h.
Anxiety - VAS
Self-assessed anxiety visual analog scale (0-100 mm). Before administering baseline, after 0.5, 1, 2, 4, 8 12, 18, 24 h.
VAS
Self-reported visual analog scale (VAS 0 - 100 mm) at rest and on movement.
Sponsors and contacts
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