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尿道周围利多卡因对女性尿动力学检查后疼痛无缓解作用:一项双盲随机对照试验。

Periurethral Lidocaine Does Not Decrease Pain After Urodynamic Testing in Women: A Double-Blinded Randomized Control Trial.

机构信息

From the Department of Obstetrics, Gynecology and Women's Health.

Atlantic Center for Research, Atlantic Health System, Morristown, NJ.

出版信息

Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):e528-e532. doi: 10.1097/SPV.0000000000000983.

Abstract

OBJECTIVE

Urodynamic testing of women is a common procedure to evaluate lower urinary tract symptoms but may cause discomfort. The objective of our study was to determine the effect of externally applied periurethral 2% lidocaine gel on pain scores after complex urodynamic testing in women.

METHODS

This prospective, double-blinded, placebo-controlled randomized trial compared 2% lidocaine gel to water-based lubricant applied to the periurethral area before urodynamic testing in women. Discomfort was measured using a visual analog pain scale (VAS) ranging from 0 to 100. The primary outcome was the difference in VAS from baseline to 4 to 6 hours after urodynamic testing. Secondary outcomes included: VAS difference from baseline to immediately postprocedure and 24 hours after urodynamic testing; VAS scores: at baseline, immediately postprocedure, after 4-6 hours, and after 24 hours; urodynamic testing results; and any adverse events. Sixty-four women per group were needed to provide a power of 80% to detect a 10-mm difference on a 100-point VAS.

RESULTS

From January 2018 to March 2019, 134 subjects were randomized, 6 subjects were excluded, which resulted in 64 subjects in both the water-based lubricant group and 2% lidocaine gel group. There was no difference in baseline demographics. There was no significant difference in the change in VAS from baseline to 4 to 6 hours after UDT (0, 0 P = 0.88). No difference in secondary outcomes was noted.

CONCLUSIONS

Topically applied 2% lidocaine gel does not decrease pain compared with water-based lubricant. For most women, complex urodynamic testing is not associated with any significant pain.Clinical Trial Registration:www.ClinicalTrials.gov,-NCT03390790, "Lidocaine for Pain After Urodynamic Testing".

摘要

目的

女性尿动力学检查是评估下尿路症状的常用方法,但可能会引起不适。本研究旨在确定在女性进行复杂尿动力学检查前在外阴部应用 2%利多卡因凝胶对疼痛评分的影响。

方法

这项前瞻性、双盲、安慰剂对照随机试验比较了 2%利多卡因凝胶和水基润滑剂在外阴部使用后对女性尿动力学检查后 4 至 6 小时疼痛评分的影响。采用视觉模拟疼痛量表(VAS)评估不适程度,范围为 0 至 100。主要结局为尿动力学检查后 4 至 6 小时 VAS 基线差异。次要结局包括:VAS 基线至即刻检查后即刻、24 小时尿动力学检查后差异;VAS 评分:基线时、即刻检查后、4-6 小时后和 24 小时后;尿动力学检查结果;以及任何不良事件。每组需要 64 名女性,以提供 80%的功率来检测 100 点 VAS 上 10 毫米的差异。

结果

2018 年 1 月至 2019 年 3 月,共有 134 名受试者被随机分配,其中 6 名受试者被排除,因此水基润滑剂组和 2%利多卡因凝胶组各有 64 名受试者。基线人口统计学特征无差异。在 UDT 后 4 至 6 小时 VAS 基线至基线的变化方面,差异无统计学意义(0,0 P = 0.88)。次要结局无差异。

结论

与水基润滑剂相比,局部应用 2%利多卡因凝胶并不能减轻疼痛。对于大多数女性来说,复杂的尿动力学检查不会引起明显的疼痛。

临床试验注册

www.ClinicalTrials.gov,-NCT03390790,“利多卡因在尿动力学检查后止痛”。

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