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CBD Knee Scope Study (CBDS)

Primary Purpose

Post-operative Pain

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol Oil
Sponsored by
Foundation for Orthopaedic Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18 or older requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury able to complete surveys and follow-up visits Exclusion Criteria: younger than 18 years of age history of knee dislocation, fracture, previous surgery, coexisting extremity pathology, *pregnancy.

Sites / Locations

  • Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Standard of Care

Cannabidiol Oil 100 mg/day

Cannabidiol Oil 200 mg/day

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Post-operative pain control
Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable.

Secondary Outcome Measures

Sleep Quality
Insomnia Severity Index .

Full Information

First Posted
June 28, 2023
Last Updated
September 11, 2023
Sponsor
Foundation for Orthopaedic Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT05934500
Brief Title
CBD Knee Scope Study
Acronym
CBDS
Official Title
Effectiveness of Cannabidiol vs. Narcotics for Post Operative Pain Control in Elective Knee Arthroscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
July 15, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Orthopaedic Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications after a knee arthroscopy.
Detailed Description
This is a prospective non-blinded randomized controlled trial with 3 groups of subjects all undergoing knee arthroscopy for soft tissue pathology. The first group will receive the SOC opioid course: 7 days of Percocet (oxycodone 5mg-acetaminophen 325mg) every four hours PO PRN, following surgery. the second 100 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively, and the third group 200 mg CBD daily for 30 days pre-operatively continuing 30 days post-operatively. All subjects in each of the three groups will undergo standard pre-operative and post-operative care, including physical exams, imaging, and education. They will only differ in pre-operative pain medication administration if they are in one of the two CBD groups. The groups will undergo surveys (sleep quality, self-reported pain, need for refill or switch to opioids). Sleep quality will be assessed with the Insomnia Severity Index (ISI) while pain, need for refill, and switch to opioids will be recorded by the patient on CRF packets. The CRF packets will be given to patients at each visit for them to fill out to the best of their ability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Opioid standard of care: Percocet (oxycodone 5mg-acetaminophen 325 mg) every 4 hours PRN postoperatively for 7 days
Arm Title
Cannabidiol Oil 100 mg/day
Arm Type
Experimental
Arm Description
CDB 100mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively
Arm Title
Cannabidiol Oil 200 mg/day
Arm Type
Experimental
Arm Description
CBD 200mg PO liquid suspension QD starting 30 days prior to surgery and finishing 30 days post-operatively.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol Oil
Intervention Description
Subjects will self administer CBD sublingually
Primary Outcome Measure Information:
Title
Post-operative pain control
Description
Numerical Pain Scale (NRS) 0 being no pain, 10 being the worst pain imaginable.
Time Frame
30 days post-operatively
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
Insomnia Severity Index .
Time Frame
30 days preoperatively leading up to surgery, then 30 days postoperatively. Outcomes will be collected from surgery to 6 weeks postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 or older requiring knee arthroscopy for soft tissue injury, acute or chronic knee injury able to complete surveys and follow-up visits Exclusion Criteria: younger than 18 years of age history of knee dislocation, fracture, previous surgery, coexisting extremity pathology, *pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Warren, RN
Phone
813-910-3688
Email
dwarren@foreonline.org
Facility Information:
Facility Name
Foundation for Orthopaedic Research and Education/ Florida Orthpaedic Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Warren, RN
Phone
813-910-3688
Email
dwarren@foreonline.org
First Name & Middle Initial & Last Name & Degree
Delbert Remaley, MD

12. IPD Sharing Statement

Learn more about this trial

CBD Knee Scope Study

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