Phase 3
Completed N=90
A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones
Urinary Stone
Source: ClinicalTrials.gov NCT04387617 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Maximum Pain Intensity Score — 3.6; 3.2 score on a scale — p=0.5
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Pain Intensity Score |
3.6; 3.2 | 0.5 |
| SECONDARY Postoperative Rescue Narcotic Use |
8; 9 | — |
| SECONDARY Total Urinary Symptoms Score |
31; 33; 27; 27 | — |
| SECONDARY The Number of Subjects With Adverse Events |
3; 2; 10; 9; 3; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04387617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.