A Multicenter, Randomized, Single-Blind Trial Evaluating a Multi-Porous Urethral Catheter with Continuous Local Ropivacaine Infusion for the Reduction of Postoperative Catheter-Related Bladder Discomfort

一项多中心、随机、单盲试验,评估多孔尿道导管联合持续局部罗哌卡因输注对减少术后导尿管相关膀胱不适的疗效

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Abstract

Background/Objectives: Catheter-related bladder discomfort (CRBD) commonly occurs in patients undergoing urologic surgery and significantly affects patient comfort and recovery. We evaluated the efficacy and safety of continuous local ropivacaine infusion using a specialized multi-porous urethral catheter in reducing postoperative CRBD. Methods: This multicenter, prospective, randomized, single-blind trial enrolled 136 male patients undergoing short-term catheterization after urologic surgery. Participants were randomized into three groups-a control group receiving saline infusion, Group 1 receiving 0.5% ropivacaine at 1 mL/h, and Group 2 receiving 0.5% ropivacaine at 2 mL/h-for up to 48 h via a multi-porous urethral catheter. The primary outcome was the incidence of CRBD at 24 h postoperatively. Secondary outcomes included changes in urethral pain assessed by a visual analog scale (VAS), urinary symptom scores, complication rates, and patient-reported catheter inconvenience and reuse intention using Likert scales. Results: The incidence of CRBD was significantly lower in Group 1 (19.6%) and Group 2 (11.1%) compared to the control group (44.4%; p = 0.001), demonstrating a clear dose-response relationship. Changes in urethral pain scores (VAS) from baseline were significantly lower in the ropivacaine groups compared to the control (p = 0.023). Complication rates were similar among groups (control 13.3%, Group 1 6.5%, Group 2 15.6%; p = 0.378), although catheter leakage occurred more frequently in Group 2, without statistical significance (p = 0.122). Conclusions: Continuous local ropivacaine infusion using a multi-porous urethral catheter effectively reduces the incidence of postoperative CRBD without increasing side effects. This approach may improve patient comfort during perioperative catheter management.

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