Intraureteral lidocaine for ureteral stent symptoms post-ureteroscopy: A randomized, phase 2, placebo-controlled trial.

Introduction: Ureteral stent and ureteral manipulation-related pain is a significant complication for patients undergoing ureteroscopy. Herein, we report a phase 2, randomized trial to assess efficacy of direct instillation of intraureteral lidocaine in reducing postoperative pain and ureteral stent symptoms.

Methods: We performed a randomized, double-blinded trial of patients undergoing elective ureteroscopy for ureteral calculi. Patients were randomized to direct instillation of 2% lidocaine plus bicarbonate, or to normal saline as control. The primary outcome of interest was early postoperative pain scores. Patients completed10-point visual analog pain scale at one-hour, two-hour, four-hour, 24-hours, four- and seven-day time points. Other outcome measurements collected included a medication diary and voiding questionnaire.

Results: A total of 41 patients were randomized in the study. Mean flank pain scores at one hour were 2.2 (±2.9) vs.1.9 (±2.4) in the intervention and placebo group, respectively (p=0.84). There was no significant difference at any time point between the intervention and placebo groups in patient-reported pain scores. Patients reported lower dysuria scores at all time points in the lidocaine group, however, none reached statistical significance. There was no difference in complication rates or adverse effects between groups.

Conclusions: In this randomized, phase 2 study, direct instillation of lidocaine into the ureter did not appear to significantly improve pain or voiding symptoms following stented ureteroscopy.