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

Phase 2

Completed

• Conditions: Urinary Stone
• Interventions: Drug: Placebo; Drug: Cannabidiol

• Registration Number: NCT04387617
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-14
• Study Start: 2021-02-15
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Results First Submitted: 2022-11-16
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-21
• Last Update Submitted: 2022-12-21
• Results First Posted: 2023-01-18
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	-
CBD Oil Group	Cannabidiol	-

Primary Outcome Measures

Name	Time	Method
Maximum Pain Intensity Score	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 Outcome Measures

Name	Time	Method
Postoperative Rescue Narcotic Use	postoperative Day 3	The number of subjects who required rescue narcotic use post ureteroscopy
Total Urinary Symptoms Score	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.
The Number of Subjects With Adverse Events	3 days post-ureteroscopy	The count of subjects who experienced adverse events

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Phoenix, Arizona, United States