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临床试验/NCT03537534
NCT03537534终止3 期

Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients

San Antonio Uniformed Services Health Education Consortium1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年4月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
发起方
入组人数
35
试验地点
1
主要终点
Subjective patient symptom score

研究概览

简要总结

Many urological conditions are diagnosed and treated with the use of endourology procedures. Unfortunately, dysuria is a common patient complaint following these procedures. Intraurethral lidocaine instillation is regularly used prior to office-based endourology procedures to alleviate dysuria, as well as, discomfort during the procedure.. Studies have confirmed that office-based procedures using intraurethral lidocaine have resulted in less patient reported dysuria. Many endourology procedures are done under general anesthesia such as urinary stone treatments or resection of bladder tumors. There is a paucity of data regarding the use of intraurethral lidocaine at the conclusion of these procedures evaluating patient reported dysuria. We have designed a prospective, randomized, placebo controlled trial to evaluate the role of intraurethral lidocaine instillation following endourology procedures in the anesthetized patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients, age 18 and older scheduled to undergo endourologic procedure to include ureteroscopy, rigid diagnostic cystoscopy, bladder biopsy, laser lithotripsy, cystolithalopaxy, and transurethral resection of bladder tumor in the operating room under general anesthesia.

排除标准

  • active urinary tract infection, current dysuria symptoms, pregnant females, urethral stricture disease, indwelling foley catheter, and history of pelvic radiation

研究组 & 干预措施

Experiment

Experimental

Lidocaine jelly (2%) 5mL x 1 dose only

干预措施: Lidocaine Jet Injector (Drug)

Placebo

Placebo Comparator

Surgilube 5mL x 1 dose only

干预措施: Placebos (Drug)

结局指标

主要结局

Subjective patient symptom score

时间窗: 1 day (immediately before and after procedure)

questionnaire scores

次要结局

  • Patient complications(within 30 days)

研究者

发起方
San Antonio Uniformed Services Health Education Consortium
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Christopher Allam

Director of Endourology and Laparoscopy

San Antonio Uniformed Services Health Education Consortium

研究点 (1)

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