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临床试验/NCT02709304
NCT02709304Unknown4 期

Exploring the Potential Efficacy of Lidocaine Gel in Reducing Discomfort in Patients Undergoing Surgical Procedures Requiring Foley Catheter Placement

Creighton University0 个研究点目标入组 40 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
40
主要终点
Decrease postoperative urinary catheter related discomfort

研究概览

简要总结

This study will evaluate whether lidocaine gel for urinary catheter insertion would decrease pain and discomfort associate with Foley catheters upon awakening from general anesthesia in the post anesthesia care unit. As a secondary objective, the study will evaluate bacterial colony counts from urine obtained from the surgical patients after insertion of the Foley catheter prior to prophylactic antimicrobial administration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 100 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Males requiring catheterization for surgical procedures scheduled for less than 4 hours.

排除标准

  • Females, patients with preexisting urological conditions, and infections

研究组 & 干预措施

Standard Gel

Placebo Comparator

Standard gel not containing local anesthetic used to insert urinary catheters.

干预措施: standard gel (Drug)

Lidocaine Gel

Experimental

lidocaine containing gel uses to insert urinary catheters

干预措施: Lidocaine gel (Drug)

结局指标

主要结局

Decrease postoperative urinary catheter related discomfort

时间窗: Within 1 hour of emergence from general anesthetic

Subject and objective pain scale

次要结局

  • decreased incidence of bacteriuria(immediate post catheter insertion and at 2 hour time point)

研究者

申办方类型
Other
责任方
Sponsor

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