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Cannabinoid

CBD Oil for Postoperative Pain (CBDS Trial)

Q: Are enrollments open for this clinical experiment?

<p>Unfortunately, clinicaltrials.gov has established that this trial is no longer enrolling patients - the initial posting was on October 1st 2022 and it's been updated as recently as July 26th 2022. However, there are 484 other trials actively looking for participants currently.</p>

Phase < 1

Recruiting

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

Requiring shoulder arthroscopic surgery for soft tissue pathology

Age 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

CBDS Trial Summary

This trial will compare the effectiveness of CBD oil to opioids in controlling post-operative pain.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, generally CBD oil may cause tiredness, changes in appetite/weight, diarrhea; opioids can lead to nausea, constipation, drowsiness and risk of dependency.

CBDS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I need shoulder surgery for a soft tissue problem.

Select...

I am 18 years old or older.

CBDS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days preoperatively leading up to surgery then 30 days postoperatively as well. 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 as well. 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 as well. 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

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 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Foundation for Orthopaedic Research and EducationLead Sponsor

13 Previous Clinical Trials

1,032 Total Patients Enrolled

Media Library

Cannabidiol Oil (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05240755 — Phase < 1

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

Postoperative Pain Clinical Trial 2023: Cannabidiol Oil Highlights & Side Effects. Trial Name: NCT05240755 — Phase < 1

Cannabidiol Oil (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05240755 — Phase < 1

Frequently Asked Questions

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

Are enrollments open for this clinical experiment?

"Unfortunately, clinicaltrials.gov has established that this trial is no longer enrolling patients - the initial posting was on October 1st 2022 and it's been updated as recently as July 26th 2022. However, there are 484 other trials actively looking for participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery

Michael C. Doarn 2022. "Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05240755.

All > Cbd > Epidiolex