Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization

Criteria

Inclusion Criteria:

• Age 18 - 70 years

• ASA 1 or 2

• Acute Radicular Pain < 12 weeks

• Pain of VAS 6 or more/ VRS moderate or more

• Radicular pain: Dermatomal pain that corresponds to physical exam and CT/MRI in the last year

Exclusion Criteria:

• Age < 18 or > 70 years

• ASA 3 or more

• Chronic radicular pain > 12 weeks

• Past spine surgery

• Intermittent Claudication due to Vascular Disease

• Diagnosed Diabetic Neuropathy

• Regular Cannabis use in past 6 months (more than once a week) OR once in last 2 weeks

• Regular opioid use in past week (Targin, Percocet, Tramadol) (Equivalent to Oxycodone 20 mg/day or more)

• Pregnancy or Lactating

• Ischemic heart disease

• Renal or hepatic failure

• History of psychiatric illness

• Cognitive impairment or inability to answer questions

• Known allergy to opioids

• Potential Loss to follow up