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Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

NCT ID: NCT06635889

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2029-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nephrolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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50 ml of 0.25% bupivacaine

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

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

placebo of 50 ml of Normal Saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type OTHER

Placebo of 50 ml of Normal Saline

Interventions

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Bupivacaine

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

Intervention Type DRUG

Normal saline

Placebo of 50 ml of Normal Saline

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luke Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Luke Reynolds, MD

Role: CONTACT

Phone: 7137926105

Email: [email protected]

Leila Yazdanbakhsh

Role: CONTACT

Email: [email protected]

Facility Contacts

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Luke Reynolds, MD

Role: primary

Leila Yazdanbakhsh

Role: backup

Other Identifiers

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IRB24-1600

Identifier Type: -

Identifier Source: org_study_id