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

Cannabis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04816994
• Other study ID #: 0092-17-HMO
• Status: Recruiting
• Phase: Phase 3
• Start date: January 7, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Radicular Back Pain
• Back Pain
• Cannabis
• Marijuana Abuse

Intervention

Drug:
• Single-dose of cannabis oil
Single-dose of cannabis oil in order to treat acute radicular pain
• Control
Giving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

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