CBD for Pain Following Orthopedic Shoulder Surgery

Description

The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery. Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery. Participants will: * track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary. * Complete two short surveys. Once before surgery and once after. * Have bloodwork tested after surgery

Conditions

Shoulder Osteoarthritis, Rotator Cuff Injuries

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Study Overview

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Study Details

Study overview

The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery. Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery. Participants will: * track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary. * Complete two short surveys. Once before surgery and once after. * Have bloodwork tested after surgery

Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical Patients: A Randomized Control Trial

CBD for Pain Following Orthopedic Shoulder Surgery

Condition
Shoulder Osteoarthritis
Intervention / Treatment

-

Contacts and Locations

Houston

Houston Methodist Hospital, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Undergoing one of the following orthopedic shoulder surgeries:
  • * Total shoulder arthroplasty
  • * Reverse total shoulder arthroplasty
  • * Shoulder hemiarthroplasty
  • * Rotator cuff repair
  • * Receiving standard anesthesia during surgery
  • * If a subject is of reproductive potential, they must be on effective contraception one month prior, during treatment, and one month following treatment.
  • * Not above the age of 18 years old
  • * History of revision shoulder arthroplasty
  • * History of liver disease or impairment
  • * Are currently taking valproate or clobazam
  • * Are currently taking a moderate/strong CYP3A4 or CYP2C19 inhibitor
  • * Are currently taking a strong CYP3A4 or CYP2C19 inducer
  • * Are currently taking narcotics
  • * History of substance/alcohol abuse
  • * Those currently or previously under the care of a pain management specialist
  • * History of marijuana/cannabidiol (not including topical) regular use within the past 6 months
  • * Allergy related to cannabidiol
  • * Allergy related to sesame seeds
  • * Pregnancy (As part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative test result is required to participate in the study.)
  • * If you are taking any medications with known risks for suicidal behavior and ideation
  • * If you have a diagnosed psychiatric or sleeping disorder
  • * If you are actively breastfeeding
  • * Patients currently taking central nervous system (CNS) depressants
  • * Patients currently taking other drugs with known hepatotoxicity
  • * Vulnerable populations.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Methodist Hospital Research Institute,

Patrick McCulloch, MD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

2027-12-30