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

NCT ID: NCT02709304

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-01-31

Brief Summary

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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

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Conditions

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Urinary Catheter Discomfort in Surgical Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard Gel

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

Group Type PLACEBO_COMPARATOR

standard gel

Intervention Type DRUG

Standard gel that is used to insert a urinary catheter that does not contain local anesthetic

Lidocaine Gel

lidocaine containing gel uses to insert urinary catheters

Group Type EXPERIMENTAL

Lidocaine gel

Intervention Type DRUG

Gel used for insertion of urinary catheter containing local anesthetic to determine if patients have less discomfort postoperatively when this is used

Interventions

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Lidocaine gel

Gel used for insertion of urinary catheter containing local anesthetic to determine if patients have less discomfort postoperatively when this is used

Intervention Type DRUG

standard gel

Standard gel that is used to insert a urinary catheter that does not contain local anesthetic

Intervention Type DRUG

Other Intervention Names

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Urojet

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Females, patients with preexisting urological conditions, and infections
Minimum Eligible Age

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark D Reisbig, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Creighton University School of Medicine / CHI Health

Central Contacts

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Mark D Reisbig, MD PhD

Role: CONTACT

402-449-4847

Other Identifiers

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693571

Identifier Type: -

Identifier Source: org_study_id

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