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Bupivacaine for Kidney Stones
Phase 2
Waitlist Available
Led By Luke Reynolds, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of nephrolithiasis planned for flexible or semi-rigid ureteroscopy in the treatment of stone disease with ureteral stenting
Be older than 18 years old
Must not have
Neurologic disease with a diagnosis of neurogenic bladder dysfunction
Dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 minutes post-emergence, 60 minutes post-emergence, 6 hours post-emergence and on post-operative day 1
Summary
This trial aims to study the effects of using bupivacaine as a pain medication after ureteroscopy for treating kidney stones. The study will compare the use of bupivacaine
Who is the study for?
This trial is for individuals undergoing ureteroscopy, a procedure to treat kidney stones. Participants should be those who are scheduled for this surgery and can provide informed consent. Specific inclusion and exclusion criteria details were not provided.
What is being tested?
The study is testing the effectiveness of bupivacaine, a local anesthetic, in reducing pain after ureteroscopy compared to normal saline (a placebo). Patients will be randomly assigned to receive either bupivacaine or saline in their bladder post-surgery.
What are the potential side effects?
Bupivacaine may cause side effects such as discomfort at the application site, dizziness, nausea, numbness around the area where it's applied. Serious side effects are rare but can include heart or nervous system problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am diagnosed with kidney stones and scheduled for a specific procedure with stenting.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a bladder condition due to nerve problems.
Select...
I am on dialysis.
Select...
I have had surgery to rebuild my bladder or ureters.
Select...
I have had radiation therapy to my pelvic area.
Select...
I have a transplanted or ectopic kidney.
Select...
I have had a surgery complication like significant bleeding or damage to my urinary system.
Select...
I might have a urinary tract infection that hasn't been treated.
Select...
I have a history of chronic pain conditions or opioid abuse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 30 minutes post-emergence, 60 minutes post-emergence, 6 hours post-emergence and on post-operative day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 minutes post-emergence, 60 minutes post-emergence, 6 hours post-emergence and on post-operative day 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-operative pain as determined by the score on a Visual Analog Scale (VAS) upon emergence from anesthesia
Secondary study objectives
Quality of life based on the Ureteral Stent Symptom Questionnaire (USSQ)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 50 ml of 0.25% bupivacaineExperimental Treatment1 Intervention
Group II: placebo of 50 ml of Normal SalinePlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
2013
Completed Phase 4
~1530
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,055 Previous Clinical Trials
760,593 Total Patients Enrolled
Luke Reynolds, MDPrincipal InvestigatorUniversity of Chicago
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