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NCT Number: NCT06635889

Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

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.

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Key information

Conditions

Nephrolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Leila Yazdanbakhsh

CONTACT

[email protected]

Luke Reynolds

PRINCIPAL_INVESTIGATOR

Luke Reynolds, MD

CONTACT

[email protected]

Theodore Karrison

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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

    Pain will be assessed using a Likert 10-point scale upon emergence from anesthesia in the recovery room, post-emergence 30 minutes, 60 minutes post-emergence and 6 and 24 hours post-emergence. These types of scales are commonly used to measure post operative pain both in anesthesia and in endourology

Secondary outcomes

  1. Milliequivalent of morphine consumed

    Time frame: From Baseline to post- operative day 5

  2. Number of bladder spasms

    Time frame: From Baseline to post- operative day 5

  3. Time to void

    Time frame: From Baseline to post- operative day 5

  4. Time to discharge

    Time frame: From Baseline to post- operative day 5

  5. Quality of life based on the Ureteral Stent Symptom Questionnaire (USSQ)

    Time frame: From Baseline to post- operative day 5

    A validated tool of 38 questions that assesses the symptoms and quality of life impact of ureteral stents.

  6. The Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Function Short Form

    Time frame: From Baseline to post- operative day 5

  7. Adverse events

    Time frame: From Baseline to post- operative day 5

Study contacts

Contact information is provided by the study sponsor or research team.

Leila Yazdanbakhsh

CONTACT

[email protected]

Luke Reynolds, MD

CONTACT

[email protected]

7137926105

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 10, 2024
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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