Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
ConditionNephrolithiasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Foley catheterization
History of allergy to bupivacaine
Antegrade ureteroscopy
Transplant or ectopic kidney
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine
DrugThe dose plan is to use 50 ml of 0.25% bupivacaine which corresponds with a total dose of 125mg.
Normal saline
Other interventionPlacebo of 50 ml of Normal Saline
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: 50 ml of 0.25% bupivacaineExperimental treatment 1 intervention
Group B: placebo of 50 ml of Normal SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post-operative pain as determined by the score on a Visual Analog Scale (VAS) upon emergence from anesthesia
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
Time frame
At 30 minutes post-emergence, 60 minutes post-emergence, 6 hours post-emergence and on post-operative day 1Secondary outcomes
1
Milliequivalent of morphine consumed
Time frame
From Baseline to post- operative day 52
Number of bladder spasms
Time frame
From Baseline to post- operative day 53
Time to void
Time frame
From Baseline to post- operative day 54
Time to discharge
Time frame
From Baseline to post- operative day 5Sponsors and contacts
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Source ClinicalTrials.gov