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

NCT ID: NCT05240755

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care

Opioid standard of care: Tramadol 50 mg PO PRN #30, Hydrocodone/Acetaminophen 5/325 PO PRN #30

Group Type NO_INTERVENTION

No interventions assigned to this group

Cannabidiol Oil 100 mg

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

Group Type EXPERIMENTAL

Cannabidiol Oil

Intervention Type DRUG

Subjects will self-administer CBD sublingually.

Cannabidiol Oil 200 mg

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

Group Type EXPERIMENTAL

Cannabidiol Oil

Intervention Type DRUG

Subjects will self-administer CBD sublingually.

Interventions

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Cannabidiol Oil

Subjects will self-administer CBD sublingually.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Foundation for Orthopaedic Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Michael C. Doarn

Principal Investigator, Clinical Professor of Orthopaedic Surgery - USF

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Florida Orthopaedic Institute

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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USF003668

Identifier Type: -

Identifier Source: org_study_id

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