Recruiting
Phase 2

Bupivacaine

Sponsor:

University of Chicago

Code:

NCT06635889

Conditions

Nephrolithiasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Bupivacaine

Normal saline

Study Details

Brief 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 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

Study ID

NCT06635889

Start date

Mar 26, 2025

Status verified date

Oct, 2025

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 50 ml of 0.25% bupivacaine

placebo comparator: placebo of 50 ml of Normal Saline

Interventions

Bupivacaine

The dose plan is to use 50 ml of 0.25% bupivacaine which corresponds with a total dose of 125mg.

Normal saline

Placebo of 50 ml of Normal Saline

Primary outcome measure

  • Post-operative pain as determined by the score on a Visual Analog Scale (VAS) upon emergence from anesthesia [ Time Frame: At 30 minutes post-emergence, 60 minutes post-emergence, 6 hours post-emergence and on post-operative day 1 ]

Central Contacts and Locations

Central contacts

Luke Reynolds, MD

7137926105lukereynolds@bsd.uchicago.edu

Leila Yazdanbakhsh

leila.yazdanbakhsh@bsd.uchicago.edu

Locations

The University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Luke Reynolds, MD

lukereynolds@bsd.uchicago.edu

Leila Yazdanbakhsh

leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator:

Luke Reynolds

More Information

Sponsor

University of Chicago

Last update posted

Nov 10, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-11-10.