Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nephrolithiasis
• Intervention / Treatment: Drug: Bupivacaine; Other: Normal saline

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Leila Yazdanbakhsh; Email: leila.yazdanbakhsh@bsd.uchicago.edu
• Study Contact Backup: Name: Luke Reynolds, MD; Phone Number: 7137926105; Email: lukereynolds@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • The University of Chicago Medical Center
      • Contact: Leila Yazdanbakhsh; Email: leila.yazdanbakhsh@bsd.uchicago.edu
      • Contact: Luke Reynolds, MD; Email: lukereynolds@bsd.uchicago.edu
      • Principal Investigator: Luke Reynolds
      • Sub-Investigator: Theodore Karrison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 ml of 0.25% bupivacaine	Drug: Bupivacaine; The dose plan is to use 50 ml of 0.25% bupivacaine which corresponds with a total dose of 125mg.
Placebo Comparator: placebo of 50 ml of Normal Saline	Other: Normal saline; Placebo of 50 ml of Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 30 minutes post-emergence, 60 minutes post-emergence, 6 hours post-emergence and on post-operative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Milliequivalent of morphine consumed		From Baseline to post- operative day 5
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
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)	A validated tool of 38 questions that assesses the symptoms and quality of life impact of ureteral stents.	From Baseline to post- operative day 5

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Luke Reynolds, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Nephrolithiasis; Organic Chemicals; Pharmaceutical Preparations; Anilides; Amides; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Bupivacaine; Saline Solution
• Other Study ID Numbers: IRB24-1600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No