Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06635889
Phase
PHASE2
Status
Recruiting
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Conditions

  • Nephrolithiasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Bupivacaine — DRUG
    The dose plan is to use 50 ml of 0.25% bupivacaine which corresponds with a total dose of 125mg.
  • Normal saline — OTHER
    Placebo of 50 ml of Normal Saline

Study Details

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.

Key Dates

Start date
Mar 26, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 50 ml of 0.25% bupivacaine
  • Placebo Comparator: 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

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Chicago Medical CenterChicagoIllinois60637
Luke Reynolds, MD
[email protected]
Leila Yazdanbakhsh
[email protected]
Luke Reynolds (PRINCIPAL_INVESTIGATOR)
Theodore Karrison (SUB_INVESTIGATOR)

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By research site
The University of Chicago Medical Center· Chicago, IL

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