NCT05240755

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for early_phase_1 postoperative-pain

Timeline
Completed

Started Jul 2022

Typical duration for early_phase_1 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

March 17, 2025

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

February 2, 2022

Last Update Submit

March 13, 2025

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain

    Numerical Pain Scale (NRS): 0 being no pain, 10 being the worst pain imaginable. Higher scores are worse outcomes.

    30 days post-operatively

Secondary Outcomes (1)

  • Sleep Quality

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

Study Arms (3)

Standard of Care

NO INTERVENTION

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

Cannabidiol Oil 100 mg

EXPERIMENTAL

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

Drug: Cannabidiol Oil

Cannabidiol Oil 200 mg

EXPERIMENTAL

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

Drug: Cannabidiol Oil

Interventions

Cannabidiol OilDRUG

Subjects will self-administer CBD sublingually.

Cannabidiol Oil 100 mgCannabidiol Oil 200 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Orthopaedic Institute

Tampa, Florida, 33736, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor of Orthopaedic Surgery - USF

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 15, 2022

Study Start

July 1, 2022

Primary Completion

June 20, 2024

Study Completion

August 20, 2024

Last Updated

March 17, 2025

Record last verified: 2024-09

Locations

US(1)