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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Illinois
The University of Chicago Medical Center
RECRUITING
Chicago
Contact Information
Primary
Luke Reynolds, MD
lukereynolds@bsd.uchicago.edu
7137926105
Backup
Leila Yazdanbakhsh
leila.yazdanbakhsh@bsd.uchicago.edu
Time Frame
Start Date: 2024-12-13
Estimated Completion Date: 2029-10
Participants
Target number of participants: 116
Treatments
Experimental: 50 ml of 0.25% bupivacaine
Placebo_comparator: placebo of 50 ml of Normal Saline
Related Therapeutic Areas
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov