CBD for Pain Following Orthopedic Shoulder Surgery
Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical Patients: A Randomized Control Trial
The Methodist Hospital Research Institute
80 participants
May 24, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- Undergoing one of the following orthopedic shoulder surgeries:
- Total shoulder arthroplasty
- Reverse total shoulder arthroplasty
- Shoulder hemiarthroplasty
- Rotator cuff repair
- 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.
Exclusion Criteria20
- Not above the age of 18 years old
- History of revision shoulder arthroplasty
- History of liver disease or impairment
- Are currently taking valproate or clobazam
- Are currently taking a moderate/strong CYP3A4 or CYP2C19 inhibitor
- Are currently taking a strong CYP3A4 or CYP2C19 inducer
- Are currently taking narcotics
- History of substance/alcohol abuse
- Those currently or previously under the care of a pain management specialist
- History of marijuana/cannabidiol (not including topical) regular use within the past 6 months
- Allergy related to cannabidiol
- Allergy related to sesame seeds
- Pregnancy (As part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative test result is required to participate in the study.)
- If you are taking any medications with known risks for suicidal behavior and ideation
- If you have a diagnosed psychiatric or sleeping disorder
- If you are actively breastfeeding
- Patients currently taking central nervous system (CNS) depressants
- Patients currently taking other drugs with known hepatotoxicity
- Vulnerable populations.
- Patients taking concomitant medications which are substrate of uridine 5'-diphospho-glucuronosyltransferase 1-9 (UGT1A9), uridine diphosphate-glucuronosyltransferase 2B7 (UGT2B7), CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and P-gp will be monitored for potential adverse events based on the Epidiolex® label for the concomitant medication being used.
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Interventions
150mg of Epidiolex
150mg of Placebo oral solution
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06381791