40 Participants Needed

CBD Oil for Postoperative Pain

(CBDS Trial)

DW
MC
Overseen ByMichael C Doarn, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Foundation for Orthopaedic Research and Education
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

How is CBD Oil different from other drugs for postoperative pain?

CBD Oil is unique because it is derived from the cannabis plant and may offer pain relief through its interaction with the body's endocannabinoid system, which is different from traditional pain medications like opioids or gabapentinoids that target different pathways. Additionally, CBD Oil is often administered orally or sublingually (under the tongue), which can be more convenient than intravenous or injectable pain medications.12345

What is the purpose of this trial?

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.

Eligibility Criteria

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

I need shoulder surgery for a soft tissue problem.
Able to complete surveys and follow-up visits

Exclusion Criteria

I have had shoulder surgery before.
I have had a shoulder dislocation.
I am under 18 years old.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants receive Cannabidiol (CBD) oil starting 30 days prior to surgery

4 weeks

Treatment

Participants receive either Cannabidiol (CBD) oil or opioid medications for post-operative pain control

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain and sleep quality assessments

6 weeks

Treatment Details

Interventions

  • Cannabidiol Oil
Trial Overview 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.
Participant Groups
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

Cannabidiol Oil is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Epidyolex for:
  • Seizures associated with Lennox-Gastaut syndrome
  • Seizures associated with Dravet syndrome
🇺🇸
Approved in United States as Epidiolex for:
  • Seizures associated with Lennox-Gastaut syndrome
  • Seizures associated with Dravet syndrome
  • Seizures associated with tuberous sclerosis complex
🇨🇦
Approved in Canada as Epidiolex for:
  • 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

Trials
16
Recruited
1,000+

Findings from Research

Effective postoperative pain management requires a multimodal approach tailored to the specific type of surgery, which can enhance patient comfort and reduce complications.
Recent advancements in pain management include the rediscovery of existing medications like Gabapentin and new combinations like oral oxycodone with naloxone, highlighting the ongoing evolution of analgesic strategies.
[New substances and applications for postoperative pain therapy].Pogatzki-Zahn, EM., Zahn, PK.[2021]
Gabapentin significantly improves postoperative pain relief and reduces opioid consumption by 20% to 62% within the first 24 hours after surgery, with a mean reduction equivalent to 30 mg of morphine.
Gabapentinoids also decrease opioid-related side effects like nausea and vomiting, while the most common side effects from gabapentin are sedation and dizziness, indicating a favorable safety profile in the postoperative setting.
Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety.Tiippana, EM., Hamunen, K., Kontinen, VK., et al.[2022]
Oral pregabalin significantly alleviates acute post-operative pain after cervicofacial surgery and reduces the need for additional pain relief medications, with a single dose of 150 mg showing the most effectiveness based on a systematic review of 11 high-quality randomized controlled trials.
The use of pregabalin was found to have no severe adverse effects, indicating it is a safe option for pain management, although the optimal dosing regimen still requires further investigation.
Oral pregabalin for acute pain relief after cervicofacial surgery: a systematic review.Liébana-Hermoso, S., Manzano-Moreno, FJ., Vallecillo-Capilla, MF., et al.[2018]

References

[New substances and applications for postoperative pain therapy]. [2021]
Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. [2022]
Oral pregabalin for acute pain relief after cervicofacial surgery: a systematic review. [2018]
Pilot Investigation of Somatosensory Functioning and Pain Catastrophizing in Pediatric Spinal Fusion Surgery. [2023]
Pattern of postoperative pain management among adult surgical patients in a low-resource setting. [2021]
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