NephrolithiasisPhase 2NCT06635889
Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
A Phase 2 study testing Bupivacaine and Normal saline in people with Nephrolithiasis, run by University of Chicago at 1 site in United States.
Trial summary
Post-operative pain and lower urinary tract symptoms are common following ureteroscopy in the treatment of stone disease. The use of bupivacaine as a topical pain medication is used routinely for other urologic procedures, however, to date there are no studies that have rigorously investigated the effect of instilling… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Bupivacaine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2025to Oct 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Leila Yazdanbakhsh contact
United States1 site, 1 recruiting
- Recruiting
The University of Chicago Medical Center
Chicago, Illinois, 60637
Luke Reynolds, MD, lukereynolds@bsd.uchicago.edu
Leila Yazdanbakhsh, leila.yazdanbakhsh@bsd.uchicago.edu
About this study
Official title: Double-Blind Randomized Placebo Controlled Trial of Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
Post-operative pain and lower urinary tract symptoms are common following ureteroscopy in the treatment of stone disease. The use of bupivacaine as a topical pain medication is used routinely for other urologic procedures, however, to date there are no studies that have rigorously investigated the effect of instilling bupivacaine in the bladder following ureteroscopy.
This is a randomized study that will investigate the effect of instilling bupivacaine in the bladder following routine ureteroscopy, laser lithotripsy and ureteral stenting in the treatment of stone disease. Compared to a placebo of Normal Saline, our study hypothesizes that administration of topical bupivacaine in the bladder will decrease post-operative pain and lower urinary tract symptoms while improving quality of life in the early post-operative period.
- Conditions
- Nephrolithiasis
- Being tested
- Bupivacaine, Normal saline
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
The dose plan is to use 50 ml of 0.25% bupivacaine which corresponds with a total dose of 125mg.
Normal salineOther
Placebo of 50 ml of Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| 50 ml of 0.25% bupivacaine | Experimental | Not described Receives: Drug: Bupivacaine |
| placebo of 50 ml of Normal Saline | Placebo comparator | Not described Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain as determined by the score on a Visual Analog Scale (VAS) upon emergence from anesthesia
Pain will be assessed using a Likert 10-point scale upon emergence from anesthesia in the recovery room, post-emergence 30 minutes, 60 minutes post-emergence and 6 and 24 hours post-emergence. These types of scales are commonly used to measure post operative pain both in anesthesia and in endourology
Measured: At 30 minutes post-emergence, 60 minutes post-emergence, 6 hours post-emergence and on post-operative day 1
Secondary outcomes (7)
Milliequivalent of morphine consumed
Measured: From Baseline to post- operative day 5
Number of bladder spasms
Measured: From Baseline to post- operative day 5
Time to void
Measured: From Baseline to post- operative day 5
Time to discharge
Measured: From Baseline to post- operative day 5
Quality of life based on the Ureteral Stent Symptom Questionnaire (USSQ)
A validated tool of 38 questions that assesses the symptoms and quality of life impact of ureteral stents.
Measured: From Baseline to post- operative day 5
The Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Function Short Form
Measured: From Baseline to post- operative day 5
Adverse events
Measured: From Baseline to post- operative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start26 Mar 2025
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luke Reynolds, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635889
- Sponsor's protocol ID
- IRB24-1600
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No