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CBD Oil for Postoperative Knee Pain (CBDS Trial)

Q: Does this experiment have open enrollment for participants?

<p>As per the clinicaltrials.gov, this medical study is not yet enrolling candidates; it was initially posted on July 15th 2023 and last updated on July 6th 2023. Notwithstanding, there are currently 493 other trials that are actively recruiting patients right now.</p>

Phase < 1

Waitlist Available

Research Sponsored by Foundation for Orthopaedic Research and Education

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days preoperatively leading up to surgery, then 30 days postoperatively. outcomes will be collected from surgery to 6 weeks postoperatively.

Awards & highlights

CBDS Trial Summary

This trial compares CBD oil to opioids to see if it can reduce post-op pain after a knee arthroscopy.

Who is the study for?

This trial is for adults over 18 who need a knee arthroscopy due to soft tissue injury or other acute or chronic knee issues. Participants must be able to fill out surveys and come back for follow-ups. It's not for those under 18, with past major knee injuries, surgeries, other limb problems, or if pregnant.Check my eligibility

What is being tested?

The study is testing the effectiveness of CBD oil in managing pain after knee surgery compared to traditional opioid medications. Patients are randomly assigned to receive either CBD oil or opioids and their pain levels are monitored.See study design

What are the potential side effects?

CBD oil may cause side effects such as tiredness, diarrhea, changes in appetite/weight. However, it's generally considered well-tolerated; specific side effects related to this trial will be closely monitored.

CBDS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I need a knee surgery for a tissue injury.

CBDS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days preoperatively leading up to surgery, then 30 days postoperatively. outcomes will be collected from surgery to 6 weeks postoperatively.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days preoperatively leading up to surgery, then 30 days postoperatively. outcomes will be collected from surgery to 6 weeks postoperatively.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days preoperatively leading up to surgery, then 30 days postoperatively. outcomes will be collected from surgery to 6 weeks postoperatively. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-operative pain control

Secondary outcome measures

Sleep Quality

Side effects data

From 2015 Phase 3 trial • 120 Patients • NCT02091375

31%

Diarrhoea

31%

Somnolence

26%

Decreased appetite

18%

Fatigue

15%

Vomiting

15%

Pyrexia

11%

Upper respiratory tract infection

11%

Lethargy

Convulsion

Weight decreased

Gamma-glutamyltransferase increased

Irritability

Cough

Transaminases increased

Status epilepticus

Nasopharyngitis

Pneumonia

Oral herpes

Platelet count

Abdominal distension

Abdominal pain

Gastrointestinal haemorrhage

Asthenia

Lower respiratory tract infection

Gamma-glutamyltransferase

Hypophagia

Hypotonia

Myoclonus

Respiratory failure

Epistaxis

Hypovolaemic shock

Aspartate aminotransferase increased

Liver function test abnormal

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

GWP42003-P 20 mg/kg/Day Dose

CBDS Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cannabidiol Oil 200 mg/dayExperimental Treatment1 Intervention

CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively.

Group II: Cannabidiol Oil 100 mg/dayExperimental Treatment1 Intervention

CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively

Group III: Standard of CareActive Control1 Intervention

Opioid standard of care: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol Oil

2020

Completed Phase 4

~10

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Foundation for Orthopaedic Research and EducationLead Sponsor

13 Previous Clinical Trials

982 Total Patients Enrolled

Media Library

Postoperative Pain Research Study Groups: Standard of Care, Cannabidiol Oil 100 mg/day, Cannabidiol Oil 200 mg/day

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment have open enrollment for participants?

"As per the clinicaltrials.gov, this medical study is not yet enrolling candidates; it was initially posted on July 15th 2023 and last updated on July 6th 2023. Notwithstanding, there are currently 493 other trials that are actively recruiting patients right now."

Answered by AI

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