CBD Oil for Postoperative Pain

(CBDS Trial)

Overseen By Michael C Doarn, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Foundation for Orthopaedic Research and Education

Disqualifiers: Shoulder dislocation, fracture, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 3 6 7 8}

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Cannabidiol Oil 200 mg Experimental Treatment 1 Intervention

CBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op

Group II: Cannabidiol Oil 100 mg Experimental Treatment 1 Intervention

CBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op

Group III: Standard of Care Active Control 1 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

Who Is Running the Clinical Trial?

Foundation for Orthopaedic Research and Education

Lead Sponsor

Trials

16

Recruited

1,000+

Published Research Related to This Trial

In a study of 32 children and adolescents undergoing spinal fusion surgery for idiopathic scoliosis, 56% experienced chronic post-surgical pain (CPSP) after surgery, with those reporting pain showing increased sensitivity to mechanical and pressure pain both at the surgical site and a control site.

Preoperative pain levels and feelings of helplessness were strong predictors of post-surgical pain, indicating that younger patients may be at higher risk for pain-related anxiety, suggesting the need for targeted psychological support and monitoring before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Investigation of Somatosensory Functioning and Pain Catastrophizing in Pediatric Spinal Fusion Surgery. Sieberg, CB., Lunde, CE., Wong, C., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral pregabalin for acute pain relief after cervicofacial surgery: a systematic review. Liébana-Hermoso, S., Manzano-Moreno, FJ., Vallecillo-Capilla, MF., et al.[2018]

In a study of 138 adult surgical patients at Ahmadu Bello University Teaching Hospital, 91.3% received intermittent intramuscular injections of opioids for postoperative pain management, indicating a reliance on traditional opioid-based methods despite the high incidence of moderate to severe pain reported by patients.

Although 78.2% of patients found the pain management satisfactory, significant side effects like nausea (32.6%) and vomiting (13.0%) were common, highlighting the need for improved multimodal pain management strategies and greater involvement of anesthetists in prescribing analgesics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pattern of postoperative pain management among adult surgical patients in a low-resource setting. Ogboli-Nwasor, E., Sule, ST., Yusufu, LM.[2021]

Citations

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These findings suggest that CBD can be considered in a postoperative multimodal pain management regimen without detrimental effects on outcome.

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Cannabidiol (CBD) Products for Pain

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In this regard, emerging evidence suggests that herbal cannabis exhibits analgesic effects in both nociceptive and neuropathic pain. Notably, at least five high ...

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CBD use also carries some risks. Though it's often well-tolerated, CBD can cause side effects, such as dry mouth, diarrhea, reduced appetite, drowsiness and ...

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Cannabidiol Adverse Effects and Toxicity - PMC

Human CBD studies for epilepsy and psychiatric disorders reported CBD-induced drug-drug interactions, hepatic abnormal-ities, diarrhea, fatigue, vomiting, and ...