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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHadassah Medical Organization

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Single-dose of cannabis oil

    Drug

    Single-dose of cannabis oil in order to treat acute radicular pain

  • Control

    Drug

    Giving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: High dose cannabis oilExperimental treatment 1 intervention
Group B: Low dose cannabis oilExperimental treatment 1 intervention
Group C: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

opioid consumption via - Patient controlled administration (PCA)

Count of patient-controlled analgesia pushes.

Time frame
The change over 24 hours

Secondary outcomes

1

Nausea and vomiting (PONV) score

PONV score (0 - 4). Before administering baseline, after 0.5, 1, 2, 4, 8 12, 18, 24 h.

Time frame
The change over 24 hours
2

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.

Time frame
The change over 24 hours
3

VAS

Self-reported visual analog scale (VAS 0 - 100 mm) at rest and on movement.

Time frame
The change over 24 hours

Other outcomes

Sponsors and contacts

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