Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

The University of Chicago

Status and phase: Enrolling; Phase 2

Conditions: Nephrolithiasis

Treatments: Other: Normal saline; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06635889

IRB24-1600

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups, including a placebo group

50 ml of 0.25% bupivacaine

Experimental group

Treatment:

Drug: Bupivacaine

placebo of 50 ml of Normal Saline

Placebo Comparator group

Treatment:

Other: Normal saline