A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones

Overview

The purpose of this study is to determine if CBD oil has any effect on decreasing postoperative pain control following ureteroscopy for urinary stone disease, and to determine if CBD oil has any effect in decreasing the amount of postoperative opioids (commonly used drug) used by patients after undergoing ureteroscopy for urinary stone disease.

Full Title of Study: “Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2022

Interventions

  • Drug: Cannabidiol
    • The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days.
  • Drug: Placebo
    • The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days

Arms, Groups and Cohorts

  • Experimental: CBD Oil Group
  • Placebo Comparator: Control Group

Clinical Trial Outcome Measures

Primary Measures

  • Post operative Pain intensity
    • Time Frame: 3 days post-ureteroscopy
    • Patient self-reported pain intensity score using a 100 mm visual analog scale

Secondary Measures

  • Postoperative opioid use
    • Time Frame: 3 days post-ureteroscopy
    • Total dosage of opioids used by patients
  • Ureteric stent symptoms
    • Time Frame: 1 and 3 days post-ureteroscopy
    • Ureteric stent Symptoms Questionnaire
  • Side effects and adverse events
    • Time Frame: 3 days post-ureteroscopy
    • post operative adverse events

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who are diagnosed with kidney or ureteral stones confirmed on imaging (CT of the abdomen and pelvis) and who elect for definitive treatment via ureteroscopy at two sites within a tertiary care institution.
  • Age 18-75 years of age.
  • Patients of either gender.
  • Patients of all ethnic backgrounds.
  • Capable of giving informed consent.
  • Capable and willing to fulfill the requirements of the study.

Exclusion Criteria

  • History of chronic pain.
  • Chronic use of opioid or other pain medication (> 12 weeks).
  • Known allergy to CBD oil or other cannabinoids.
  • Known or suspected pregnancy.
  • Inability to give informed consent or unable to meet requirements of the study for any reason.
  • Bilateral ureteroscopy.
  • Current marijuana, cannabidiol (CBD), or dronabinol use.
  • Liver disease/cirrhosis.
  • Current treatment of seizures with clobazam, valproate, or other antiepileptic medications.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Karen L. Stern, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Karen Stern, MD, Principal Investigator, Mayo Clinic

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.