- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02709304
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
Status
Unknown
Intervention / Treatment
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
- Name: Mark D Reisbig, MD PhD
- Phone Number: 402-449-4847
- Email: mdr44643@creighton.edu
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:
|
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 693571
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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