Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381791
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-04-11
Brief Title:
CBD for Pain Following Orthopedic Shoulder Surgery
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Cannabidiol CBD As A Pain Adjunct in Orthopedic Surgical Patients A Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBD
Brief 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
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
Detailed Description:
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 CBDplacebo at their postoperative appointment
Subjects will also be asked to complete validated questionnaires via Houston Methodists 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
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 CBDplacebo at their postoperative appointment
Subjects will also be asked to complete validated questionnaires via Houston Methodists 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None