CBD Oil for Postoperative Pain
(CBDS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether CBD oil (Cannabidiol Oil) can manage post-surgery pain as effectively as traditional opioid painkillers, such as Tramadol or Hydrocodone. Researchers will divide participants into groups, with one group receiving CBD oil and the other receiving standard opioid medications. The trial is ideal for individuals undergoing shoulder surgery who are open to trying CBD oil for pain relief instead of opioids. Participants must have scheduled shoulder arthroscopic surgery and be able to complete surveys and follow-up visits. As an Early Phase 1 trial, this study focuses on understanding how CBD oil works in people, offering participants a chance to explore this alternative pain management option.
Do I need to stop my current medications for the CBD oil trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that Cannabidiol (CBD) is generally safe for use. Studies indicate it can help manage pain without negative effects. However, CBD may cause side effects such as dry mouth, diarrhea, reduced appetite, and drowsiness.
Some studies also mention more serious side effects, like liver problems and fatigue, though these are less common. The FDA has approved CBD for other uses, suggesting that its benefits usually outweigh the risks.
In early trials like this one, researchers closely monitor safety. Participants might experience mild to moderate side effects, but these trials help ensure safety for wider use in the future.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using cannabidiol (CBD) oil for postoperative pain because it offers a natural alternative to traditional opioid painkillers like Tramadol and Hydrocodone/Acetaminophen. Unlike these opioids, which can be addictive and come with significant side effects, CBD oil is derived from the cannabis plant and is non-addictive. Additionally, CBD oil works by interacting with the body's endocannabinoid system, which may help reduce inflammation and pain without the high risk of dependency associated with opioids. This could make CBD oil a safer option for managing pain after surgery.
What evidence suggests that this trial's treatments could be effective for postoperative pain?
Research has shown that CBD oil might help reduce pain after surgery. For example, one study found that patients using CBD reported up to 25% less pain within two days after surgery compared to those who didn't use it. Another study suggested that CBD can be part of a pain management plan without affecting recovery. However, a review of several studies showed that CBD often didn't make a significant difference in pain relief. Overall, while some results are promising, the evidence on CBD's effectiveness for reducing pain after surgery remains mixed. This trial will compare the effects of two different dosages of Cannabidiol Oil (100 mg and 200 mg) with the standard of care for postoperative pain management.13678
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Participants receive Cannabidiol (CBD) oil starting 30 days prior to surgery
Treatment
Participants receive either Cannabidiol (CBD) oil or opioid medications for post-operative pain control
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain and sleep quality assessments
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidiol Oil
Cannabidiol Oil is already approved in European Union, United States, Canada for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Foundation for Orthopaedic Research and Education
Lead Sponsor