Health TrialsbyHealthPanel

CBD for Pain Following Orthopedic Shoulder Surgery

ConditionsShoulder OsteoarthritisRotator Cuff Injuries
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute

About this trial

The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery.

Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery.

Participants will:

* track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary. * Complete two short surveys. Once before surgery and once after. * Have bloodwork tested after surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Above the age of 18 years old

Undergoing a rotator cuff repair surgery

Receiving standard anesthesia during surgery

If a subject is of reproductive potential, they must be on effective contraception one month prior, during treatment, and one month following treatment.

Disqualifiers

Under the age of 18 years old

History of revision shoulder arthroplasty

History of liver disease or impairment

Are currently taking valproate or clobazam

Trial design

Design model

Parallel

Treatments tested in this trial

  • Epidiolex

    Drug

    150mg of Epidiolex

  • Placebo oral solution

    Drug

    150mg of Placebo oral solution

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Epidiolex (cannabidiol)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary - Pain Journal

Evaluation of postoperative pain journal responses from subjects. The pain diary will track their pain level on a Visual Analogue Scale (VAS) and their documented pain medication usage.

Time frame
2 weeks

Secondary outcomes

1

Survey Data

Evaluation of the survey data and questionnaires from baseline to the end of the two weeks post operative period.

Time frame
2 weeks
2

Pain Disability Index (PDI)

This survey is designed to measure the degree to which aspects of a participant's life are disrupted by chronic pain. Each item on the survey is rated on an eleven point scale from no disability (0) to worst disability (10).

Time frame
2 weeks
3

Pain, Enjoyment, General Activity (PEG) Scale

This survey tracks a participant's pain intensity and pain interference. Each item on the survey is rated on an eleven point scale from 0 to 10 with different measures at either end of the scale depending on which item (intensity or interference) is being evaluated.

Time frame
2 weeks
4

Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety

This survey measures how frequently a patient was bothered by symptoms of anxiety or depression. It is measured on a four point scale from 0-3 with each number corresponding to how often a patient experienced a symptom with 0 being not at all, and 3 being nearly every day.

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Methodist Hospital Research Institute

Lead sponsor

Source ClinicalTrials.gov
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