Urinary Stone
Conditions
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.
Interventions
DRUGCannabidiol
The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days.
DRUGPlacebo
The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBD Oil Group Cannabidiol: The product is a liquid formulation that was prescribed at a dosage of 20 mg per day for a total of 3 days. | 45 |
| Control Group Placebo: The product is a liquid formulation placebo that was prescribed at an equivalent volume as active drug for 3 days | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | Control Group | Total | CBD Oil Group |
|---|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 14.4 | 59.7 years STANDARD_DEVIATION 13.37 | 61.0 years STANDARD_DEVIATION 12.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 45 participants | 90 participants | 45 participants |
| Sex: Female, Male Female | 27 Participants | 55 Participants | 28 Participants |
| Sex: Female, Male Male | 18 Participants | 35 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 24 / 45 | 21 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
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.
Time frame: postoperative Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBD Oil Group | Maximum Pain Intensity Score | 3.6 score on a scale | Standard Deviation 2.4 |
| Control Group | Maximum Pain Intensity Score | 3.2 score on a scale | Standard Deviation 2.8 |
p-value: 0.595% CI: [-0.8, 1.6]t-test, 2 sided
Secondary
Postoperative Rescue Narcotic Use
The number of subjects who required rescue narcotic use post ureteroscopy
Time frame: postoperative Day 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CBD Oil Group | Postoperative Rescue Narcotic Use | 8 Participants |
| Control Group | Postoperative Rescue Narcotic Use | 9 Participants |
Secondary
The Number of Subjects With Adverse Events
The count of subjects who experienced adverse events
Time frame: 3 days post-ureteroscopy
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CBD Oil Group | The Number of Subjects With Adverse Events | Constipation | 10 Participants |
| CBD Oil Group | The Number of Subjects With Adverse Events | Diarrhea | 3 Participants |
| CBD Oil Group | The Number of Subjects With Adverse Events | Poor appetite | 8 Participants |
| CBD Oil Group | The Number of Subjects With Adverse Events | Poor sleep | 11 Participants |
| CBD Oil Group | The Number of Subjects With Adverse Events | Drowiness | 11 Participants |
| CBD Oil Group | The Number of Subjects With Adverse Events | Dizziness | 7 Participants |
| CBD Oil Group | The Number of Subjects With Adverse Events | Tiredness | 17 Participants |
| CBD Oil Group | The Number of Subjects With Adverse Events | Itching | 2 Participants |
| CBD Oil Group | The Number of Subjects With Adverse Events | Headache | 4 Participants |
| CBD Oil Group | The Number of Subjects With Adverse Events | Nausea | 3 Participants |
| Control Group | The Number of Subjects With Adverse Events | Itching | 2 Participants |
| Control Group | The Number of Subjects With Adverse Events | Constipation | 9 Participants |
| Control Group | The Number of Subjects With Adverse Events | Dizziness | 5 Participants |
| Control Group | The Number of Subjects With Adverse Events | Diarrhea | 1 Participants |
| Control Group | The Number of Subjects With Adverse Events | Nausea | 2 Participants |
| Control Group | The Number of Subjects With Adverse Events | Poor appetite | 4 Participants |
| Control Group | The Number of Subjects With Adverse Events | Tiredness | 13 Participants |
| Control Group | The Number of Subjects With Adverse Events | Poor sleep | 5 Participants |
| Control Group | The Number of Subjects With Adverse Events | Headache | 4 Participants |
| Control Group | The Number of Subjects With Adverse Events | Drowiness | 8 Participants |
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.
Time frame: postoperative day 1 and postoperative day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBD Oil Group | Total Urinary Symptoms Score | Postoperative day 1 | 31 score on a scale | Standard Deviation 5.5 |
| CBD Oil Group | Total Urinary Symptoms Score | Postoperative day 3 | 27 score on a scale | Standard Deviation 5.8 |
| Control Group | Total Urinary Symptoms Score | Postoperative day 1 | 33 score on a scale | Standard Deviation 6.6 |
| Control Group | Total Urinary Symptoms Score | Postoperative day 3 | 27 score on a scale | Standard Deviation 6.9 |