Meryam El Issaoui, Marlene Elmelund, Niels Klarskov
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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.ResultsWe 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; <jats:italic>P</jats:italic> < 0.001). Adverse events and patient satisfaction did not significantly differ between the alkalinised lidocaine and placebo treatments (<jats:italic>P</jats:italic> = 0.825 and <jats:italic>P</jats:italic> = 0.138, respectively).ConclusionsIntravesical instillation of alkalinised lidocaine before BTX‐A injections significantly reduced VAS pain scores compared to placebo (<jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" xlink:href=\"http://clinicaltrials.gov\">ClinicalTrials.gov</jats:ext-link> identifier: NCT05415865).","PeriodicalId":8985,"journal":{"name":"BJU International","volume":"58 1","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Alkalinised lidocaine as an anaesthetic before onabotulinumtoxinA injections. a randomised trial\",\"authors\":\"Meryam El Issaoui, Marlene Elmelund, Niels Klarskov\",\"doi\":\"10.1111/bju.16647\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"ObjectivesTo evaluate the effect of intravesical alkalinised lidocaine as an anaesthetic treatment on procedural pain during intradetrusor onabotulinumtoxinA (BTX‐A) injections for overactive bladder.Patients and MethodsThis 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.ResultsWe 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; <jats:italic>P</jats:italic> < 0.001). Adverse events and patient satisfaction did not significantly differ between the alkalinised lidocaine and placebo treatments (<jats:italic>P</jats:italic> = 0.825 and <jats:italic>P</jats:italic> = 0.138, respectively).ConclusionsIntravesical instillation of alkalinised lidocaine before BTX‐A injections significantly reduced VAS pain scores compared to placebo (<jats:ext-link xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\" xlink:href=\\\"http://clinicaltrials.gov\\\">ClinicalTrials.gov</jats:ext-link> identifier: NCT05415865).\",\"PeriodicalId\":8985,\"journal\":{\"name\":\"BJU International\",\"volume\":\"58 1\",\"pages\":\"\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2025-01-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BJU International\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/bju.16647\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BJU International","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/bju.16647","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的探讨膀胱内碱化利多卡因麻醉对膀胱过度活动症患者肌内注射肉毒杆菌毒素A (BTX‐A)时手术性疼痛的影响。患者和方法这项单中心、随机、双盲、安慰剂对照的两期交叉试验于2022年9月至2024年5月在我们的门诊泌尿妇科诊所进行了BTX - A注射。在第一个治疗期间,患者被随机分配(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)、氯化钠(9g /L, 10ml)组成。配套安慰剂为氯化钠(9 g/L, 40 mL)。主要结局指标是100毫米视觉模拟量表(VAS)评定的程序性疼痛。次要结局包括不良反应,如需要导尿的空后残留尿量、尿路感染、治疗后1周血尿,以及以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。结果:我们纳入了50例患者,其中41例符合每个方案分析的条件。膀胱内碱化利多卡因VAS评分(平均21.3 mm, 95%可信区间[CI] 14.7-27.8 mm)显著低于安慰剂(平均41.6 mm, 95% CI 35.0-48.1 mm),平均差异为- 20.3 mm (95% CI - 29.2至- 11.5 mm;P & lt;0.001)。碱化利多卡因和安慰剂治疗的不良事件和患者满意度无显著差异(P = 0.825和P = 0.138)。结论:与安慰剂相比,BTX‐A注射前膀胱内灌注碱化利多卡因可显著降低VAS疼痛评分(ClinicalTrials.gov识别码:NCT05415865)。
Alkalinised lidocaine as an anaesthetic before onabotulinumtoxinA injections. a randomised trial
ObjectivesTo evaluate the effect of intravesical alkalinised lidocaine as an anaesthetic treatment on procedural pain during intradetrusor onabotulinumtoxinA (BTX‐A) injections for overactive bladder.Patients and MethodsThis 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.ResultsWe 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).ConclusionsIntravesical instillation of alkalinised lidocaine before BTX‐A injections significantly reduced VAS pain scores compared to placebo (ClinicalTrials.gov identifier: NCT05415865).
期刊介绍:
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