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临床试验/CTRI/2024/08/072047
CTRI/2024/08/072047尚未招募不适用

Transurethral Ropivacaine (100mg) bladder irrigation reduces the incidence of bladder discomfort in transurethral resection of bladder tumor.

Institute of Medical Science1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
162
试验地点
1
主要终点
To know the effect of Ropivacaine on reduction of irritative symptoms in transurethral resection of bladder tumor

研究概览

简要总结

We want to conduct a Case Control study to know the effect of Ropivacaine (100mg) to reduce the bladder discomfort happening post-operatively after Transurethral resection of bladder tumor . In case , 81 patients’ bladder shall be irrigated with Inj. Ropivacaine 100mg in 500 ml Normal Saline at the end of surgery over 10-15 mins while In Control ,81 Patients shall be irrigated with 0.9% Normal Saline without Inj Ropivacaine . Thereafter patients will be asked to answer a set of Questionnaire regarding bladder discomfort and other urinary symptoms at interval of one hour for 6 hours post surgery. At the end the responses of all the patients in Case and Control sets will be evaluated to depict the significance of Inj. Ropivacaine 100mg in mitigating the bladder discomfort in such patients

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
35.00 Year(s) 至 75.00 Year(s)(—)
性别
Male

入选标准

  • Those undergoing transurethral resection of bladder tumor patients belonging to ASA physical status type 1&2.

排除标准

  • Patients refusal Age less than 35 years and more than 75 years Patients having Coronary Artery Disease Hemodynamic unstability Cardiac Conduction Defect Coronary Artery Disease Morbid Obesity Allergy to study drugs.

结局指标

主要结局

To know the effect of Ropivacaine on reduction of irritative symptoms in transurethral resection of bladder tumor

时间窗: Baseline when drug will be used | At every 15 minute for 1st hour. | At every 30 minute for 2nd and 3rd hour. | At every hour for 5 hours.

次要结局

  • To know duration of hospital stay(To know duration of significant hematuria and post-op bladder irrigation duration)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Rajeev Ranjan

Institute of Medical Science,BHU, Varanasi

研究点 (1)

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