CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 118 enrolled
Drug / intervention
Pregabalin 300mg +1 moredrug
Likely dose
Pregabalin 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04122196
NCT04122196Phase 3Completed

Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Ureteral Stent Symptoms After Ureteroscopy: a Randomized Controlled Trial

University of Missouri-Columbia·interventional·Posted Oct 10, 2019·Updated Nov 12, 2025

In Brief

A Phase 3 clinical trial evaluating Pregabalin 300mg and Placebo oral tablet for Kidney Stone and 3 related conditions. Completed, enrolled 118 participants across 1 site.

Detailed Summary

This is a randomized, placebo-controlled, double-blinded study examining the use of perioperative pregabalin in ureteroscopy with stent placement. Ureteroscopy is typically performed for kidney or ureteral stones, but may be performed for other reasons such as for the diagnosis and possible treatment of certain kinds of cancers. As part of the same surgery, a ureteral stent is often placed. The surgery and the stent can cause discomfort, and patients may receive narcotic pain medicine. In other surgeries, a single dose of pregabalin, around one hour before surgery has been shown to decrease the need for pain medication after the surgery. This work will test whether this is true in ureteroscopy by giving eligible patients who agree to participate either pregabalin or a placebo shortly before surgery then examining how much pain medication they use after surgery. A placebo is an inactive medication. Neither the study participant nor the study staff will know who received pregabalin and who received placebo until after the study is over. For completing surveys, patients will receive compensation for their time in the form of gift certificates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 10, 2019
Enrollment StartJun 1, 2020
Primary CompletionJul 1, 2023
Study CompletionJul 1, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.7 years ago

Interventions

Pregabalin 300mgdrug

Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.

Placebo oral tabletdrug

Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.