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Completed

NCT Number: NCT04387617

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

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.

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Key information

Conditions

Urinary Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Cannabidiol

Drug

The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days.

Other names: Epidiolex

Placebo

Drug

The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days

Primary outcomes

  1. Maximum Pain Intensity Score

    Time frame: postoperative Day 3

    Patient self-reported maximum pain intensity score measured by the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable.

Secondary outcomes

  1. Postoperative Rescue Narcotic Use

    Time frame: postoperative Day 3

    The number of subjects who required rescue narcotic use post ureteroscopy

  2. Total Urinary Symptoms Score

    Time frame: postoperative day 1 and postoperative day 3

    Patient self-reported urinary symptoms measured by the Ureteric Stent Symptoms Questionnaire (USSQ) urinary symptoms section. Following insertion of the stents, subjects were asked to answer 11 questions regarding their urinary symptoms. 9 questions used a score of 1 to 5, where 1 was never and 5 was all of the time. 1 question used a score of 1 to 4, where 1 was do not see any blood and 4 was urine is heavily blood stained. 1 question used a score of 1 to 7, where 1 was delighted and 7 was terrible. Total sum of all 11 questions for a total score ranging from 11 - 56, lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction.

  3. The Number of Subjects With Adverse Events

    Time frame: 3 days post-ureteroscopy

    The count of subjects who experienced adverse events

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 14, 2020
Registry last updated
Jan 18, 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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