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NCT06635889 | NOT YET RECRUITING | Nephrolithiasis

Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
Sponsor:

University of Chicago

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.

Condition or disease

Nephrolithiasis

Intervention/treatment

Bupivacaine

Normal saline

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 116 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Double-Blind Randomized Placebo Controlled Trial of Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2029-10
Estimated Study Completion Date : 2029-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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)
Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

Location Details

NCT06635889

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How to Participate

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Locations

Not yet recruiting

United States, Illinois

The University of Chicago Medical Center

Chicago, Illinois, United States, 60637