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Completed

NCT Number: NCT04672252

The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy

This study is designed to evaluate the effects of administering CBD to control post-operative pain in patients undergoing shoulder arthroscopy. Secondly, the purpose will be to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing an arthroscopic shoulder procedure (rotator cuff repair, decompression, labrum repair)
  • Patients ages 18-75, inclusive
  • Female patients must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly
  • Male patients must be using an effective form of contraception

Exclusion criteria

  • Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
  • Younger than 18 years of age
  • Older than 75 years of age
  • Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners
  • History of cannabis abuse or dependence
  • History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values
  • History of stroke or acute coronary syndromes within 3 months before surgery
  • Abnormal coagulation profile
  • Renal failure (serum creatinine > 250 μmol/L [2.83 mg/dL]) or liver cirrhosis
  • Patients with a history of hypersensitivity to Percocet
  • Patients that have been on pre-operative opioid management for any reason
  • Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder
  • Patients diagnosed with major depression, psychosis, or substance abuse disorder
  • Patients with current or a history of suicidal ideation
  • Breastfeeding females
  • Patients with clinically significant illness, including cardiovascular disorders
  • Clinically significant lab abnormalities
  • Abnormal LFTs
  • Patients with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain/head injury, or seizures
  • Patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C).
  • Patients taking moderate or strong inhibitors of CYP3A4 and CYP2C19 (listed below) concomitantly
  • Patients taking strong CYP3A4 and CYP2C19 inducers (listed below) concomitantly
  • Patients taking substrates of UTG1A9, UTGB17, CYP2A1, CYP2B6, CYP2C8, CYP2C9 and CYP2C19 (listed below) concomitantly

Treatment and study plan

CBD Oral Disintegrating Tablet (ODT)

Drug

Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen

Placebo ODT

Other

Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.

The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.

Primary outcomes

  1. Pain Visual Analog Scale (VAS) Score

    Time frame: Hour 24 Post-Surgery

    Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).

  2. Pain Visual Analog Scale (VAS) Score

    Time frame: Day 2 Post-Surgery

    Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).

  3. Pain Visual Analog Scale (VAS) Score

    Time frame: Day 7 Post-Surgery

    Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).

  4. Pain Visual Analog Scale (VAS) Score

    Time frame: Day 14 Post-Surgery

    Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).

  5. Nausea Score on VAS Scale

    Time frame: Day 2 Post-Surgery

    Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).

  6. Nausea Score on VAS Scale

    Time frame: Day 7 Post-Surgery

    Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).

  7. Nausea Score on VAS Scale

    Time frame: Day 14 Post-Surgery

    Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).

Secondary outcomes

  1. Total Opioid Consumption

    Time frame: Day 1 Post-Surgery

    Consumption based on patient-self-report

  2. Total Opioid Consumption

    Time frame: Day 2 Post-Surgery

    Consumption based on patient-self-report.

  3. Total Opioid Consumption

    Time frame: Day 7 Post-Surgery

    Consumption based on patient-self-report.

  4. Total Opioid Consumption

    Time frame: Day 14 Post-Surgery

    Consumption based on patient-self-report.

  5. Number of Completed Doses Out of 3 Maximum Doses/Day

    Time frame: Day 1 Post-Surgery

    Based on patient-self-report.

  6. Number of Completed Doses Out of 3 Maximum Doses/Day

    Time frame: Day 7 Post-Surgery

    Based on patient-self-report.

  7. Number of Completed Doses Out of 3 Maximum Doses/Day

    Time frame: Day 14 Post-Surgery

    Based on patient-self-report.

  8. Patient Satisfaction Score

    Time frame: Hour 24 Post-Surgery

    Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

  9. Patient Satisfaction Score

    Time frame: Day 2 Post-Surgery

    Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

  10. Patient Satisfaction Score

    Time frame: Day 7 Post-Surgery

    Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

  11. Patient Satisfaction Score

    Time frame: Day 14 Post-Surgery

    Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Orcosa Inc.

Registry information

Official study title

The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy; A Double-Blind, Randomized Control Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 17, 2020
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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