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

ABSTRACT: 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.

SUBMITTER: Roberts G

PROVIDER: S-EPMC5963444 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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

Roberts Gregory G Leslie Robert R Robb Sylvia S Siemens D Robert DR Beiko Darren D

Canadian Urological Association journal = Journal de l'Association des urologues du Canada 20171001 10

<h4>Introduction</h4>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.<h4>Methods</h4>We performed a randomized, double-blinded trial of patients undergoing elective ureteroscopy for ureteral calculi. Patients were randomized to direct instillation of 2 ...[more]

PMID: 29382444

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Project description:IntroductionWe aimed to assess the effects of postoperative ureteral stent placement after uncomplicated ureteroscopy.MethodsWe performed a comprehensive search with no restrictions on publication language or status up to February 1, 2019. We only included randomized trials. Two review authors independently examined full-text reports, identified relevant studies, assessed the eligibility of studies for inclusion, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model and assessed the certainty of the evidence according to GRADE.ResultsWe included 23 studies with 2656 randomized patients. Primary outcomes: It is uncertain whether stenting reduces the number of unplanned return visits (very low certainty of evidence [CoE]). Pain on the day of surgery is probably similar (mean difference [MD] 0.32; 95% confidence interval (CI) -0.13-0.78; moderate CoE). Pain on postoperative days 1-3 may show little to no difference (standardized mean difference [SMD] 0.25; 95% CI -0.32-0.82; low CoE). It is uncertain whether stented patients experience more pain on postoperative days 4-30 (very low CoE). Stenting may result in little to no difference in the need for secondary interventions (risk ratio [RR] 1.15; 95% CI 0.39-3.33; low CoE).Secondary outcomesWe are uncertain whether stenting reduces the need for narcotics and reduces ureteral stricture rates up to 90 days (very low CoE). Rates of hospital admission may be slightly reduced (RR 0.70; 95% CI 0.32-1.55; low CoE). This review was limited to patients in whom ureteroscopy was deemed 'uncomplicated.' In addition, time intervals for the grouping for the reported degree of pain were established post-hoc. The CoE for most outcomes was rated as low or very low for methodological reasons.ConclusionsFindings of this review illustrate the tradeoffs of risks and benefits faced by urologists and their patients when it comes to decision-making about stent placement after uncomplicated ureteroscopy for stone disease.

Project description:ObjectivesTo assess the feasibility of conducting a randomised controlled trial (RCT) to assess whether avoiding ureteric drainage is superior to performing ureteric drainage after Uncomplicated Ureteroscopy and/or Flexible Ureterorenoscopy (URS/FURS) treatment of a urinary tract stone in improving patient reported outcome measures (PROMs) and 30-day unplanned readmission rates. A secondary objective was to understand current practice of urologists regarding ureteric drainage after uncomplicated URS/FURS (UU).Material and methodsWe undertook an online survey of urologists, circulated amongst members of international urological societies and through social media platforms. Uncomplicated URS/FURS was defined as completion of URS/FURS treatment for a urinary tract stone, with the absence of: ureteral trauma, residual fragments requiring further lithotripsy procedures, significant bleeding, perforation, prior urinary tract infection or pregnancy. The ureteric drainage options considered included an indwelling stent, stent on a string or a ureteric catheter. The primary outcome was to determine the proportion of urologists willing to take part in a RCT, randomising patients after UU to a "no ureteric drainage" arm or ureteric drainage arm. Secondary outcomes included determining in their current practice, the proportion of clinicians performing routine ureteric drainage after UU, the reasons for performing ureteric drainage following UU and their preferred optimal duration for ureteric drainage if it is used. The study was reported according to the Checklist for Reporting Results of Internet E-Surveys (CHERRIES).ResultsTotal of 468 respondents from 45 countries took part in the survey, of whom 303 completed the entire survey (65%). The majority agreed that they would be willing to randomise patients (244/303, 81%) in the proposed RCT. Perceived lack of equipoise to randomise was the most common reason for not being willing to participate (59/303, 19%).92% (308/335) reported that they use ureteric drainage after UU. This was most often due to wanting to prevent possible complications from post-operative ureteric oedema (77%) or to aid passage of small fragments (43%). Complexity of the case (i.e. impacted stone 90%) and length of the procedure (46%) were the most important intraoperative factors influencing the decision to use ureteric drainage post procedure. If required, the median stated ideal duration of ureteric drainage was 5 days (IQR: 3-7 days) after UU. If having UU personally, 30% would want no stent postoperatively and over half would prefer a stent on a string.ConclusionWe have highlighted wide variation in practice regarding ureteric drainage after UU. Our results support the feasibility of an RCT evaluating if no ureteric drainage is superior to ureteric drainage in improving PROMs and 30-day unplanned readmission rates following UU.

Dataset Information

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

Publications

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

Similar Datasets

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