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Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

NCT06635889 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-11-10

No results posted yet for this study

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

Interventions

DRUG

Bupivacaine

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

OTHER

Normal saline

Placebo of 50 ml of Normal Saline

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Luke Reynolds, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2029-10-31
Completion
2029-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06635889 on ClinicalTrials.gov