Using CBD to manage pain after shoulder surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of Epidiolex (cannabidiol) as an additional pain management option for patients who have undergone orthopedic shoulder surgery. Participants will be randomly assigned to receive either Epidiolex or a placebo alongside their standard pain management regimen. They will track their pain levels and medication use in a diary for two weeks post-surgery, with follow-up calls from researchers to monitor compliance and safety. Bloodwork and surveys will be conducted to assess safety and pain outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Above the age of 18 years old
* Undergoing a rotator cuff repair surgery
* 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.

Exclusion Criteria:

* Under 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 disorder
* If you are untreated for a diagnosed 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.

Patients taking concomitant medications which are substrate of uridine 5'-diphospho-glucuronosyltransferase 1-9 (UGT1A9), uridine diphosphate-glucuronosyltransferase 2B7 (UGT2B7), CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and P-gp will be monitored for potential adverse events based on the Epidiolex® label for the concomitant medication being used.

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Patrick McCulloch, MD — The Methodist Hospital Research Institute
• Study coordinator: Haley M Goble, MPH, CRCC
• Email: hmgoble@houstonmethodist.org
• Phone: 7134413930

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rotator cuff repair with biceps rerouting and dermal graft augmentation for large, difficult tears

  This study tests a combined surgical approach to see if it helps tendon retear rates in adults with large rotator cuff tears that are hard to repair.

  Recruiting Tam Anh Research Institute · Ho Chi Minh City, Ho Chi Minh · NCT07875556

• Muscle Thickness, Trunk Proprioception, and Postural Stability in Rotator Cuff Pathology

  This study tests whether trunk and abdominal muscle thickness and sense of position relate to shoulder problems from rotator cuff issues, by comparing people with rotator cuff pathology to healthy controls.

  Recruiting Istanbul Medeniyet University · Istanbul, Kadıköy · NCT07744165

• Single-shot nerve block with IV dexamethasone for rebound pain after shoulder surgery

  This trial tests whether giving a one-time shoulder nerve block plus an IV dexamethasone dose can prevent rebound pain after shoulder surgery.

  Recruiting Phase 4 Seoul National University Hospital · Seoul, Jongno-gu · NCT07699744

• Two anesthesia methods to keep the joint clear during shoulder arthroscopy

  This trial tests whether inhaled sevoflurane vs. total intravenous anesthesia with propofol affects how well surgeons can see inside the shoulder during rotator cuff repair.

  Recruiting Centre Hospitalier Universitaire de Nice · Nice, Alpes-Maritimes · NCT07628244

• Concentric vs Eccentric Full Can Exercise for Partial Rotator Cuff Tears

  This study tests whether concentric or eccentric full can exercises are more effective for improving shoulder pain and muscle structure in people with partial rotator cuff tears.

  Recruiting Firat University · Elâzığ, MErkez · NCT07587931

• Tracking recovery after arthroscopic shoulder and knee surgeries

  This will follow people having routine arthroscopic shoulder or knee surgery to see if patient characteristics, tear details, or surgical choices predict better recovery and function over two years.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07501013

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.