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Effectiveness of Cannabidiol Vs. Narcotics for Post Operative Pain Control in Elective Shoulder Arthroscopic Surgery (CBDS)

F

Foundation for Orthopaedic Research and Education

Status and phase

Completed
Early Phase 1

Conditions

Post-operative Pain

Treatments

Drug: Cannabidiol Oil

Study type

Interventional

Funder types

Other

Identifiers

NCT05240755
USF003668

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 18 years or older
  • Requiring shoulder arthroscopic surgery for soft tissue pathology
  • Able to complete surveys and follow-up visits

Exclusion criteria

  • Younger than 18 years of age
  • Shoulder dislocation, fracture, previous surgery, coexisting extremity pathology, pregnancy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 3 patient groups

Standard of Care
No Intervention group
Description:
Opioid standard of care: Tramadol 50 mg PO PRN #30, Hydrocodone/Acetaminophen 5/325 PO PRN #30
Cannabidiol Oil 100 mg
Experimental group
Description:
CBD 100 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
Treatment:
Drug: Cannabidiol Oil
Cannabidiol Oil 200 mg
Experimental group
Description:
CBD 200 mg PO liquid suspension QD starting 30 days prior and finishing 30 days post-op
Treatment:
Drug: Cannabidiol Oil

Trial contacts and locations

1

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Central trial contact

Debbi Warren; Michael C Doarn, MD

Data sourced from clinicaltrials.gov

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