Epidiolex
150mg of Epidiolex
Cannabidiol Oral SolutionLoading study record…
Loading study record…
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
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-04-16
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Subjects will be randomized according to their surgery type. They will receive either the Epidiolex cannabidiol in addition to their standard of care pain regimen or a placebo in addition to their standard of care pain regimen. They will be asked to track a pain diary for 2 weeks postoperatively. A member of the research team will conduct a follow-up telephone call on day 7 to assess subjects' drug compliance. Subjects will also be contacted for a safety monitoring call at day 7 and 1 week after completion of treatment in which they will disclose type, severity, onset, and duration of any adverse events. In addition, they will complete a suicidal assessment10 See attached safety screening document. After the 2 weeks, subjects will return the pain diary and vial of CBD/placebo at their postoperative appointment. Subjects will also be asked to complete validated questionnaires via Houston Methodist's Redcap system once before surgery and again at 14 days postop. The surveys are with regards to sleep, activity, and pain and should take no more than 15 minutes to complete. At their standard of care postoperative visit (11-17 days following surgery), another liver panel will be taken and their final safety monitoring screening will be conducted.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
150mg of Epidiolex
Cannabidiol Oral Solution150mg of Placebo oral solution
PlaceboEligibility
primary outcomes
Time frame: 2 weeks
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.
secondary outcomes
Time frame: 2 weeks
Evaluation of the survey data and questionnaires from baseline to the end of the two weeks post operative period.
Time frame: 2 weeks
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
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
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
This survey assesses the amount and quality of sleep that a patient has experienced in the last month. It is measured both with general free response questions and scaled questions reflecting frequency or lack thereof for a given issue (rated from Not during the past month to Three or more times a week).
Publications
No exact PMID-linked public article is currently readable locally.