RECRUITING

Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-13
Study Completion:2029-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06635889

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. * Male or female, aged ≥ 18 years old.
  4. * Diagnosis of nephrolithiasis planned for flexible or semi-rigid ureteroscopy in the treatment of stone disease with ureteral stenting.
  1. * Foley catheterization
  2. * History of allergy to bupivacaine
  3. * Antegrade ureteroscopy
  4. * Transplant or ectopic kidney
  5. * Ureteral or bladder reconstruction
  6. * Pregnancy (which is a contraindication to elective ureteroscopy)
  7. * Dialysis
  8. * Surgical complication (significant bleeding, ureteral perforation, significant urothelial damage)
  9. * Suspicion of untreated urinary tract infection
  10. * History of pelvic radiation
  11. * Neurologic disease with a diagnosis of neurogenic bladder dysfunction
  12. * History of chronic pain (fibromyalgia, interstitial cystitis, opioid abuse)

Contacts and Locations

Study Contact

Luke Reynolds, MD
CONTACT
7137926105
lukereynolds@bsd.uchicago.edu
Leila Yazdanbakhsh
CONTACT
leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator

Luke Reynolds, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

The University of Chicago Medical Center
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Luke Reynolds, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-13
Study Completion Date2029-10

Study Record Updates

Study Start Date2024-12-13
Study Completion Date2029-10

Terms related to this study

Additional Relevant MeSH Terms

  • Nephrolithiasis