Efficacy of Lidocaine Gel in Reducing Foley Catheter Discomfort in Surgical Patients

Phase 4

• Conditions: Urinary Catheter Discomfort in Surgical Patients
• Interventions: Drug: standard gel; Drug: Lidocaine gel

• Registration Number: NCT02709304
• Lead Sponsor: Creighton University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-11
• Last Update Submitted: 2016-03-11
• Study First Posted: 2016-03-16
• Last Update Posted: 2016-03-16
• Study Start: 2016-04
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• Females, patients with preexisting urological conditions, and infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Gel	standard gel	Standard gel not containing local anesthetic used to insert urinary catheters.
Lidocaine Gel	Lidocaine gel	lidocaine containing gel uses to insert urinary catheters

Primary Outcome Measures

Name	Time	Method
Decrease postoperative urinary catheter related discomfort	Within 1 hour of emergence from general anesthetic	Subject and objective pain scale

Secondary Outcome Measures

Name	Time	Method
decreased incidence of bacteriuria	immediate post catheter insertion and at 2 hour time point	Urine culture and colony counts