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Recruiting NCT06635889

Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

Phase II Interventional Nephrolithiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bupivacaine, Normal saline.
Who it may be relevant to
Registry conditions: Nephrolithiasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Milliequivalent of morphine consumed [Time frame: From Baseline to post- operative day 5]
  • Number of bladder spasms [Time frame: From Baseline to post- operative day 5]
  • Time to void [Time frame: From Baseline to post- operative day 5]
  • Time to discharge [Time frame: From Baseline to post- operative day 5]
  • Quality of life based on the Ureteral Stent Symptom Questionnaire (USSQ) [Time frame: From Baseline to post- operative day 5]
  • The Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Function Short Form [Time frame: From Baseline to post- operative day 5]
  • Adverse events [Time frame: From Baseline to post- operative day 5]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Chicago Medical Center — Chicago

Identifiers

NCT: NCT06635889 · IRB24-1600

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗