Post-operative PainEarly Phase 1CBDSNCT05240755
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery
A Early Phase 1 study testing Cannabidiol Oil in people with Post-operative Pain, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
Trial summary
This study is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Cannabidiol Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 20 Aug 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Requiring shoulder arthroscopic surgery for soft tissue pathology
- Able to complete surveys and follow-up visits
Who cannot join
- Younger than 18 years of age
- Shoulder dislocation, fracture, previous surgery, coexisting extremity pathology, pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications.
- Conditions
- Post-operative Pain
- Being tested
- Cannabidiol Oil
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol OilDrug
Subjects will self-administer CBD sublingually.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Opioid standard of care: Tramadol 50 mg PO PRN #30, Hydrocodone/Acetaminophen 5/325 PO PRN #30 |
| Cannabidiol Oil 100 mg | Experimental | CBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op Receives: Drug: Cannabidiol Oil |
| Cannabidiol Oil 200 mg | Experimental | CBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op Receives: Drug: Cannabidiol Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Numerical Pain Scale (NRS): 0 being no pain, 10 being the worst pain imaginable. Higher scores are worse outcomes.
Measured: 30 days post-operatively
Secondary outcomes (1)
Sleep Quality
Insomnia Severity Index
Measured: 30 days preoperatively leading up to surgery then 30 days postoperatively as well. Outcomes will be collected from surgery to 6 weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Jul 2022
- Primary completion20 Jun 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael C. Doarn, Foundation for Orthopaedic Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240755
- Sponsor's protocol ID
- USF003668
- Acronym
- CBDS
- Status last verified
- Sep 2024
- First submitted
- 2 Feb 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery
- ClinicalTrials.gov ID
- NCT05240755
- Acronym / sponsor ID
- CBDS / USF003668
- Conditions
- Post-operative Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Opioid standard of care: Tramadol 50 mg PO PRN #30, Hydrocodone/Acetaminophen 5/325 PO PRN #30 |
| Cannabidiol Oil 100 mg | Experimental | Drug: Cannabidiol OilCBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op |
| Cannabidiol Oil 200 mg | Experimental | Drug: Cannabidiol OilCBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Requiring shoulder arthroscopic surgery for soft tissue pathology
- Able to complete surveys and follow-up visits
Key exclusion criteria (2 listed)
- Younger than 18 years of age
- Shoulder dislocation, fracture, previous surgery, coexisting extremity pathology, pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol OilSubjects will self-administer CBD sublingually. | Drug | Cannabidiol Oil 100 mg, Cannabidiol Oil 200 mg |
Primary outcome
Post-operative pain
Time frame: 30 days post-operatively
Numerical Pain Scale (NRS): 0 being no pain, 10 being the worst pain imaginable. Higher scores are worse outcomes.
1 secondary outcome
Sleep Quality
Time frame: 30 days preoperatively leading up to surgery then 30 days postoperatively as well. Outcomes will be collected from surgery to 6 weeks postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cannabidiol Oil in people with Post-operative Pain, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 30 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.