Clinical trial NCT06635889: Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
Official title: Double-Blind Randomized Placebo Controlled Trial of Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nephrolithiasis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Post-operative pain as determined by the score on a Visual Analog Scale (VAS) upon emergence from anesthesia
timeFrame: At 30 minutes post-emergence, 60 minutes post-emergence, 6 hours post-emergence and on post-operative day 1
Secondary outcomes:
measure: Milliequivalent of morphine consumed
timeFrame: From Baseline to post- operative day 5
measure: Number of bladder spasms
timeFrame: From Baseline to post- operative day 5
measure: Time to void
timeFrame: From Baseline to post- operative day 5
measure: Time to discharge
timeFrame: From Baseline to post- operative day 5
measure: Quality of life based on the Ureteral Stent Symptom Questionnaire (USSQ)
timeFrame: From Baseline to post- operative day 5
measure: The Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Function Short Form
timeFrame: From Baseline to post- operative day 5
measure: Adverse events
timeFrame: From Baseline to post- operative day 5
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Luke Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References: