CBD for Pain Following Orthopedic Shoulder Surgery
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
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
Treatments tested in this trial
- Epidiolex
- Placebo oral solution
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov