Nephrolithiasis
Conditions
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.
Interventions
DRUGBupivacaine
The dose plan is to use 50 ml of 0.25% bupivacaine which corresponds with a total dose of 125mg.
OTHERNormal saline
Placebo of 50 ml of Normal Saline
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain as determined by the score on a Visual Analog Scale (VAS) upon emergence from anesthesia | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of bladder spasms | From Baseline to post- operative day 5 | — |
| Time to void | From Baseline to post- operative day 5 | — |
| Time to discharge | From Baseline to post- operative day 5 | — |
| Milliequivalent of morphine consumed | From Baseline to post- operative day 5 | — |
| The Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Function Short Form | From Baseline to post- operative day 5 | — |
| Adverse events | From Baseline to post- operative day 5 | — |
| Quality of life based on the Ureteral Stent Symptom Questionnaire (USSQ) | 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. |
Countries
United States
Contacts
Primary ContactLuke Reynolds, MD
Backup ContactLeila Yazdanbakhsh
Outcome results
None listed