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Cannabinoid
CBD Oil for Postoperative Pain (CBDS Trial)
Phase < 1
Recruiting
Research Sponsored by Foundation for Orthopaedic Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Requiring shoulder arthroscopic surgery for soft tissue pathology
Age 18 years or older
Must not have
Shoulder dislocation
Younger than 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days preoperatively leading up to surgery then 30 days postoperatively as well. outcomes will be collected from surgery to 6 weeks postoperatively.
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial will compare the effectiveness of CBD oil to opioids in controlling post-operative pain.
Who is the study for?
This trial is for adults over 18 needing shoulder arthroscopic surgery due to soft tissue issues. Participants must be able to complete surveys and follow-up visits. It's not for those under 18, with a history of shoulder dislocation or fracture, previous shoulder surgeries, other limb problems, or who are pregnant.
What is being tested?
The study compares the effectiveness of CBD oil versus traditional opioid medications in managing pain after elective shoulder arthroscopy. It's a forward-looking (prospective), randomized trial where patients don't know which treatment they're getting.
What are the potential side effects?
While specific side effects aren't listed here, generally CBD oil may cause tiredness, changes in appetite/weight, diarrhea; opioids can lead to nausea, constipation, drowsiness and risk of dependency.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need shoulder surgery for a soft tissue problem.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a shoulder dislocation.
Select...
I am under 18 years old.
Select...
I have a shoulder fracture.
Select...
I have had shoulder surgery before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days preoperatively leading up to surgery then 30 days postoperatively as well. outcomes will be collected from surgery to 6 weeks postoperatively.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days preoperatively leading up to surgery then 30 days postoperatively as well. outcomes will be collected from surgery to 6 weeks postoperatively.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-operative pain
Secondary study objectives
Sleep Quality
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Cannabidiol Oil 200 mgExperimental Treatment1 Intervention
CBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
Group II: Cannabidiol Oil 100 mgExperimental Treatment1 Intervention
CBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
Group III: Standard of CareActive Control1 Intervention
Opioid standard of care: Tramadol 50 mg PO PRN #30, Hydrocodone/Acetaminophen 5/325 PO PRN #30
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved
Find a Location
Who is running the clinical trial?
Foundation for Orthopaedic Research and EducationLead Sponsor
14 Previous Clinical Trials
951 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need shoulder surgery for a soft tissue problem.I have had shoulder surgery before.I have had a shoulder dislocation.I am under 18 years old.I am 18 years old or older.You have another health issue in your arms or legs.I have a shoulder fracture.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Cannabidiol Oil 100 mg
- Group 3: Cannabidiol Oil 200 mg
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.