Using bupivacaine to reduce pain after ureteroscopy for kidney stones
Double-Blind Randomized Placebo Controlled Trial of Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
This study tests if using bupivacaine in the bladder after kidney stone surgery can help reduce pain and improve comfort for patients.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06635889 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of instilling bupivacaine in the bladder after ureteroscopy, a procedure for treating kidney stones. It is a randomized trial comparing the effects of bupivacaine against a placebo (normal saline) on post-operative pain and urinary symptoms. The hypothesis is that bupivacaine will lead to reduced pain and improved quality of life in patients following the procedure. Participants will be monitored for their pain levels and urinary symptoms in the early post-operative period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with nephrolithiasis who are scheduled for ureteroscopy.
Not a fit: Patients with a history of allergy to bupivacaine or those with certain medical conditions such as chronic pain syndromes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative pain and improve recovery for patients undergoing ureteroscopy.
How similar studies have performed: While the use of bupivacaine in other urologic procedures is common, this specific application following ureteroscopy has not been rigorously tested before, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female, aged ≥ 18 years old. * Diagnosis of nephrolithiasis planned for flexible or semi-rigid ureteroscopy in the treatment of stone disease with ureteral stenting. Exclusion Criteria: * Foley catheterization * History of allergy to bupivacaine * Antegrade ureteroscopy * Transplant or ectopic kidney * Ureteral or bladder reconstruction * Pregnancy (which is a contraindication to elective ureteroscopy) * Dialysis * Surgical complication (significant bleeding, ureteral perforation, significant urothelial damage) * Suspicion of untreated urinary tract infection * History of pelvic radiation * Neurologic disease with a diagnosis of neurogenic bladder dysfunction * History of chronic pain (fibromyalgia, interstitial cystitis, opioid abuse)
Where this trial is running
Chicago, Illinois
- The University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Luke Reynolds, MD — University of Chicago
- Study coordinator: Luke Reynolds, MD
- Email: lukereynolds@bsd.uchicago.edu
- Phone: 7137926105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.