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

March 11, 2016 updated by: Creighton University

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard Gel
Standard gel not containing local anesthetic used to insert urinary catheters.
Standard gel that is used to insert a urinary catheter that does not contain local anesthetic
Experimental: Lidocaine Gel
lidocaine containing gel uses to insert urinary catheters
Gel used for insertion of urinary catheter containing local anesthetic to determine if patients have less discomfort postoperatively when this is used
Other Names:
  • Urojet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease postoperative urinary catheter related discomfort
Time Frame: Within 1 hour of emergence from general anesthetic
Subject and objective pain scale
Within 1 hour of emergence from general anesthetic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
decreased incidence of bacteriuria
Time Frame: immediate post catheter insertion and at 2 hour time point
Urine culture and colony counts
immediate post catheter insertion and at 2 hour time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mark D Reisbig, MD PhD, Creighton University School of Medicine / CHI Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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