El Issaoui Meryam, Elmelund Marlene, Klarskov Niels
Department of Obstetrics and Gynecology, Herlev and Gentofte University Hospital, Herlev, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
BJU Int. 2025 Apr;135(4):638-647. doi: 10.1111/bju.16647. Epub 2025 Jan 11.
To evaluate the effect of intravesical alkalinised lidocaine as an anaesthetic treatment on procedural pain during intradetrusor onabotulinumtoxinA (BTX-A) injections for overactive bladder.
This single-centre, randomised, double-blind, placebo-controlled two period crossover trial was conducted on women scheduled for BTX-A injections at our outpatient urogynaecology clinic between September 2022 and May 2024. Patients were randomly assigned (1:1) to receive either alkalinised lidocaine or placebo during the first treatment period. Alkalinised lidocaine solution comprised lidocaine hydrochloride (20 mg/mL, 20 mL), sodium hydrogen carbonate (1 mmoL/mL, 10 mL), and sodium chloride (9 g/L, 10 mL). The matching placebo was sodium chloride (9 g/L, 40 mL). The primary outcome measure was procedural pain rated on a 100-mm visual analogue scale (VAS). Secondary outcomes included adverse effects such as post-void residual urine volumes requiring catheterisation, urinary tract infection, haematuria 1 week after treatment, and patient satisfaction measured on a 5-point scale. During the second treatment period, patients received the alternative intervention.
We enrolled 50 patients, of which 41 were eligible for per-protocol analyses. The mean VAS score was significantly lower following intravesical alkalinised lidocaine (mean 21.3 mm, 95% confidence interval [CI] 14.7-27.8 mm) compared to placebo (mean 41.6 mm, 95% CI 35.0-48.1 mm) with a mean difference of -20.3 mm (95% CI -29.2 to -11.5 mm; P < 0.001). Adverse events and patient satisfaction did not significantly differ between the alkalinised lidocaine and placebo treatments (P = 0.825 and P = 0.138, respectively).
Intravesical instillation of alkalinised lidocaine before BTX-A injections significantly reduced VAS pain scores compared to placebo (ClinicalTrials.gov identifier: NCT05415865).
评估膀胱内注入碱化利多卡因作为麻醉治疗对膀胱过度活动症患者行逼尿肌内注射A型肉毒毒素（BTX-A）时操作疼痛的影响。
本单中心、随机、双盲、安慰剂对照的两阶段交叉试验于2022年9月至2024年5月在我们门诊泌尿妇科诊所计划接受BTX-A注射的女性患者中进行。患者在第一个治疗期被随机分配（1:1）接受碱化利多卡因或安慰剂。碱化利多卡因溶液由盐酸利多卡因（20mg/mL，20mL）、碳酸氢钠（1mmol/mL，10mL）和氯化钠（9g/L，10mL）组成。匹配的安慰剂为氯化钠（9g/L，40mL）。主要结局指标是用100mm视觉模拟量表（VAS）对操作疼痛进行评分。次要结局包括不良事件，如导尿所需的排尿后残余尿量、尿路感染、治疗后1周血尿，以及用5分制测量的患者满意度。在第二个治疗期，患者接受替代干预。
我们纳入了50例患者，其中41例符合符合方案分析的条件。与安慰剂（平均41.6mm，95%置信区间[CI]35.0 - 48.1mm）相比，膀胱内注入碱化利多卡因后的平均VAS评分显著更低（平均21.3mm，95%CI 14.7 - 27.8mm），平均差值为 - 20.3mm（95%CI - 29.2至 - 11.5mm；P < 0.001）。碱化利多卡因和安慰剂治疗之间的不良事件和患者满意度无显著差异（分别为P = 0.825和P = 0.138）。
与安慰剂相比，在BTX-A注射前膀胱内灌注碱化利多卡因显著降低了VAS疼痛评分（ClinicalTrials.gov标识符：NCT05415865）。
