Post-operative PainEarly Phase 1CBDSNCT05934500
CBD Knee Scope Study
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 is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications after a knee arthroscopy. 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2023to 30 Dec 2025
- 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 or older
- requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury
- able to complete surveys and follow-up visits
Who cannot join
- younger than 18 years of age
- history of knee dislocation, fracture, previous surgery, coexisting extremity pathology, *pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute
Tampa, Florida, 33637
About this study
Official title: Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Knee Arthroscopic Surgery
This is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications after a knee arthroscopy.
Read the detailed description
This is a prospective non-blinded randomized controlled trial with 3 groups of subjects all undergoing knee arthroscopy for soft tissue pathology. The first group will receive the SOC opioid course: 7 days of Percocet (oxycodone 5mg-acetaminophen 325mg) every four hours PO PRN, following surgery. the second 100 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively, and the third group 200 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively.
All subjects in each of the three groups will undergo standard pre-operative and post-operative care, including physical exams, imaging, and education. They will only differ in pre-operative pain medication administration if they are in one of the two CBD groups. The groups will undergo surveys (sleep quality, self-reported pain, need for refill or switch to opioids). Sleep quality will be assessed with the Insomnia Severity Index (ISI) while pain, need for refill, and switch to opioids will be recorded by the patient on CRF packets. The CRF packets will be given to patients at each visit for them to fill out to the best of their ability.
- 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: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days |
| Cannabidiol Oil 100 mg/day | Experimental | CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively Receives: Drug: Cannabidiol Oil |
| Cannabidiol Oil 200 mg/day | Experimental | CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively. Receives: Drug: Cannabidiol Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain control
Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable.
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. 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 posted7 Jul 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Why it stopped: insufficient drug supply at the time.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934500
- Sponsor's protocol ID
- USF006030
- Acronym
- CBDS
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2023
- Last updated
- 25 Sep 2026
- 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 25 Sep 2026. 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 Knee Arthroscopic Surgery
- ClinicalTrials.gov ID
- NCT05934500
- Acronym / sponsor ID
- CBDS / USF006030
- Conditions
- Post-operative Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: insufficient drug supply at the time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Jul 2023 (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 is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications after a knee arthroscopy.
Detailed description
This is a prospective non-blinded randomized controlled trial with 3 groups of subjects all undergoing knee arthroscopy for soft tissue pathology. The first group will receive the SOC opioid course: 7 days of Percocet (oxycodone 5mg-acetaminophen 325mg) every four hours PO PRN, following surgery. the second 100 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively, and the third group 200 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively.
All subjects in each of the three groups will undergo standard pre-operative and post-operative care, including physical exams, imaging, and education. They will only differ in pre-operative pain medication administration if they are in one of the two CBD groups. The groups will undergo surveys (sleep quality, self-reported pain, need for refill or switch to opioids). Sleep quality will be assessed with the Insomnia Severity Index (ISI) while pain, need for refill, and switch to opioids will be recorded by the patient on CRF packets. The CRF packets will be given to patients at each visit for them to fill out to the best of their ability.
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: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days |
| Cannabidiol Oil 100 mg/day | Experimental | Drug: Cannabidiol OilCDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively |
| Cannabidiol Oil 200 mg/day | Experimental | Drug: Cannabidiol OilCBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively. |
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 or older
- requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury
- able to complete surveys and follow-up visits
Key exclusion criteria (2 listed)
- younger than 18 years of age
- history of knee 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/day, Cannabidiol Oil 200 mg/day |
Primary outcome
Post-operative pain control
Time frame: 30 days post-operatively
Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable.
1 secondary outcome
Sleep Quality
Time frame: 30 days preoperatively leading up to surgery, then 30 days postoperatively. Outcomes will be collected from surgery to 6 weeks postoperatively.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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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: withdrawn, as of the sponsor's last update on 25 Sep 2026. 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 was withdrawn before enrolling participants, so there are no results.
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 control (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 25 Sep 2026.