CBD for Pain Following Orthopedic Shoulder Surgery

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Apr 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of Epidiolex, a form of cannabidiol (CBD), to see if it helps reduce pain after orthopedic shoulder surgery. The researchers want to find out if Epidiolex can work as an additional pain medication for patients recovering from surgeries like total shoulder replacements and rotator cuff repairs. They will compare the effects of Epidiolex to a placebo, which is an inactive solution, to determine its effectiveness and safety.

To participate, you need to be between 18 and 74 years old and scheduled for one of the specified shoulder surgeries. Participants will track their pain and medications in a diary and will receive calls from researchers once a week to discuss their progress. They will also fill out two short surveys and have some blood tests done after surgery. It's important to note that certain medical conditions or medications may prevent you from joining the study, so please check with your doctor if you're interested. This trial is currently recruiting participants, and your involvement could help improve pain management for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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 Criteria:
• • 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.