NCT06635889

Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

Double-Blind Randomized Placebo Controlled Trial of Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-03-26
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2024-10-10
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study