Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients
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
- 是
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
Lidocaine jelly (2%) 5mL x 1 dose only
干预措施: Lidocaine Jet Injector (Drug)
Placebo
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
Christopher Allam
Director of Endourology and Laparoscopy
San Antonio Uniformed Services Health Education Consortium
