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

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Stone

Intervention / Treatment
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* Drug: Cannabidiol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBD Oil Group<br> | Drug: Cannabidiol<br>* The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days.<br>* Other names: Epidiolex;|
| Placebo Comparator: Control Group<br> | Drug: Placebo<br>* The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Rescue Narcotic Use | The number of subjects who required rescue narcotic use post ureteroscopy | postoperative Day 3 | 
| 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 | 
| The Number of Subjects With Adverse Events | The count of subjects who experienced adverse events | 3 days post-ureteroscopy |