NCT02709304

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

March 9, 2016

Last Update Submit

March 11, 2016

Conditions

Urinary Catheter Discomfort in Surgical Patients

Keywords

urinary catheter discomfort

Outcome Measures

Primary Outcomes (1)

  • Decrease postoperative urinary catheter related discomfort

    Subject and objective pain scale

    Within 1 hour of emergence from general anesthetic

Secondary Outcomes (1)

  • decreased incidence of bacteriuria

    immediate post catheter insertion and at 2 hour time point

Study Arms (2)

Standard Gel

PLACEBO COMPARATOR

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

Drug: standard gel

Lidocaine Gel

EXPERIMENTAL

lidocaine containing gel uses to insert urinary catheters

Drug: Lidocaine gel

Interventions

Lidocaine gelDRUG

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

Also known as: Urojet
Lidocaine Gel
standard gelDRUG

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

Standard Gel

Eligibility Criteria

Age19 Years - 100 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Females, patients with preexisting urological conditions, and infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mark D Reisbig, MD PhD

    Creighton University School of Medicine / CHI Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark D Reisbig, MD PhD

CONTACT

402-449-4847mdr44643@creighton.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 16, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 16, 2016

Record last verified: 2016-03