Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

NCT06635889 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB24-1600
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrolithiasis

Outcome Measures

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

  At 30 minutes post-emergence, 60 minutes post-emergence, 6 hours post-emergence and on post-operative day 1

Secondary Outcomes (7)

• 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

• Quality of life based on the Ureteral Stent Symptom Questionnaire (USSQ)

  From Baseline to post- operative day 5

Study Arms (2)

50 ml of 0.25% bupivacaine

EXPERIMENTAL

Drug: Bupivacaine

placebo of 50 ml of Normal Saline

PLACEBO COMPARATOR

Other: Normal saline

Interventions

Bupivacaine DRUG

The dose plan is to use 50 ml of 0.25% bupivacaine which corresponds with a total dose of 125mg.

50 ml of 0.25% bupivacaine

Normal saline OTHER

Placebo of 50 ml of Normal Saline

placebo of 50 ml of Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Luke Reynolds, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luke Reynolds, MD

CONTACT

7137926105; lukereynolds@bsd.uchicago.edu

Leila Yazdanbakhsh

CONTACT

leila.yazdanbakhsh@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: March 26, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)