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碱化利多卡因溶液作为透明质酸钠局部注射治疗膀胱过度活动症的一线局部麻醉方案:一项双盲随机对照试验的结果。

Alkalinized lidocaine solution as a first-line local anesthesia protocol for intradetrusor injection of onabotulinum toxin A: Results from a double-blinded randomized controlled trial.

机构信息

Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.

Clínica Universitária de Urologia, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.

出版信息

Neurourol Urodyn. 2020 Nov;39(8):2471-2479. doi: 10.1002/nau.24519. Epub 2020 Sep 21.

Abstract

AIMS

Local anesthesia protocols for intradetrusor onabotulinum toxin A (BoNTA) injection lack standardization. We aimed to determine if an alkalinized lidocaine solution is more effective than lidocaine only.

METHODS

Patients of both genders aged 18 or above enlisted for intradetrusor BoNTA injection (idiopathic, neurogenic, and bladder pain syndrome) were included in a double-blinded randomized controlled trial after obtaining their informed consent. All participants filled a bladder diary and a urine culture was performed. Subjects were randomized 1:1 to Protocol A (20 ml 2% lidocaine + 10 ml 8.4% sodium bicarbonate) or Protocol B (20 ml 2% lidocaine + 10 ml 0.9% saline solution). A Numeric Rating Scale (0-10) was used to assess the level of pain immediately after the procedure (primary endpoint). Secondary endpoints included pain after 1 h, urinary tract infection, acute urinary retention, and hematuria related to the procedure.

RESULTS

A total of 116 patients were randomized. Baseline characteristics (age, sex, indication, and bladder diary parameters) of patients in Group A and B were similar. Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01). No differences were observed 1 h after treatment (Protocol A and B, respectively, 0.54 ± 0.17 vs. 0.69 ± 0.19, p = .487). The only adverse event reported was mild-to-moderate self-limited hematuria in 15.4% of patients.

CONCLUSIONS

The use of an alkalinized lidocaine solution has proven to be significantly superior to lidocaine only as local anesthesia before intradetrusor BoNTA injection, suggesting that this may be considered a first-line option.

摘要

目的

用于膀胱内注射肉毒毒素 A(BoNTA)的局部麻醉方案缺乏标准化。我们旨在确定碱化利多卡因溶液是否比单纯利多卡因更有效。

方法

在获得知情同意后,我们将入组的所有年龄在 18 岁或以上的男女患者纳入一项双盲随机对照试验,这些患者患有膀胱内 BoNTA 注射的适应证(特发性、神经性和膀胱疼痛综合征)。所有参与者均填写了膀胱日记,并进行了尿液培养。将患者以 1:1 的比例随机分为方案 A(20ml2%利多卡因+10ml8.4%碳酸氢钠)或方案 B(20ml2%利多卡因+10ml0.9%生理盐水溶液)。使用数字评分量表(0-10)来评估手术结束后即刻的疼痛程度(主要终点)。次要终点包括术后 1 小时的疼痛、尿路感染、急性尿潴留和与手术相关的血尿。

结果

共随机分配了 116 例患者。两组患者的基线特征(年龄、性别、适应证和膀胱日记参数)相似。碱化溶液的手术结束时疼痛评分明显较低(方案 A 和 B 分别为 2.37±0.31 与 4.44±0.36,p<0.01)。治疗后 1 小时观察到的差异无统计学意义(方案 A 和 B 分别为 0.54±0.17 与 0.69±0.19,p=0.487)。仅报告了 15.4%的患者出现轻度至中度自限性血尿的不良事件。

结论

与单纯使用利多卡因相比,在膀胱内 BoNTA 注射前使用碱化利多卡因溶液作为局部麻醉已被证明具有显著优势,这表明它可能被视为一线选择。

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