Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

Last updated: January 10, 2025
Sponsor: University of Chicago
Overall Status: Active - Recruiting

Phase

2

Condition

Kidney Stones

Treatment

Normal saline

Bupivacaine

Clinical Study ID

NCT06635889
IRB24-1600
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of signed and dated informed consent form

  • Stated willingness to comply with all study procedures and availability for theduration of the study.

  • Male or female, aged ≥ 18 years old.

  • Diagnosis of nephrolithiasis planned for flexible or semi-rigid ureteroscopy in thetreatment of stone disease with ureteral stenting.

Exclusion

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, significanturothelial 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

Total Participants: 116
Treatment Group(s): 2
Primary Treatment: Normal saline
Phase: 2
Study Start date:
December 13, 2024
Estimated Completion Date:
October 31, 2029

Connect with a study center

  • The University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

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