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

Urinary Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387617
• Other study ID #: 19-011832
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 15, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Calculi
• Urinary Stone
• Urolithiasis

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Pain Intensity Score	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.	postoperative Day 3
Secondary	Postoperative Rescue Narcotic Use	The number of subjects who required rescue narcotic use post ureteroscopy	postoperative Day 3
Secondary	Total Urinary Symptoms Score	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.	postoperative day 1 and postoperative day 3
Secondary	The Number of Subjects With Adverse Events	The count of subjects who experienced adverse events	3 days post-ureteroscopy

External Links

•   Mayo Clinic Clinical Trials