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

Study Overview
=================
Brief 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

Official Title
-----------------
Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement: A Double Blinded, Randomized, 24 Hours Follow-up Study

Conditions
-----------------
Acute Radicular Back Pain, Cannabis

Intervention / Treatment
-----------------
* Drug: Single-dose of cannabis oil
* Drug: Control


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose cannabis oil<br>Single-dose 20.0 mg tetrahydrocannabinol + 20 mg cannabidiol, Sub-linguistic. | Drug: Single-dose of cannabis oil<br>* Single-dose of cannabis oil in order to treat acute radicular pain<br>|
| Experimental: Low dose cannabis oil<br>Single-dose 10 mg tetrahydrocannabinol + 10 mg cannabidiol, Sub-linguistic. | Drug: Single-dose of cannabis oil<br>* Single-dose of cannabis oil in order to treat acute radicular pain<br>|
| Placebo Comparator: Control<br>Single-dose Olive oil that is similar in appearance and taste to cannabis oil | Drug: Control<br>* Giving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radicular pain- VAS | Self-reported visual analog scale (VAS 0 - 100 mm) at rest and on movement. | The change over 24 hours | 
| opioid consumption via - Patient controlled administration (PCA) | Count of patient-controlled analgesia pushes. | The change over 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting (PONV) score | PONV score (0 - 4). Before administering baseline, after 0.5, 1, 2, 4, 8 12, 18, 24 h. | The change over 24 hours | 
| 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. | The change over 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute radicular back pain, Cannabis