Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride

Henry Ford Health

Status and phase

Completed

Phase 4

Conditions

Safety Issues

Pain

Spray

Treatments

Drug: Gebauer's Ethyl Chloride

Drug: Gebauer's Pain Ease Top Aerosol Mist Spray

Study type

Interventional

Funder types

Other

Identifiers

NCT04207710

12932

Details and patient eligibility

About

This study aims to determine if Gebauer's Pain Ease or Gebauer's Ethyl Chloride topical anesthetic sprays are safe for use as numbing agents prior to placing epidurals and arterial lines, based on whether they introduce increased microbial growth after application to skin. Due to the recent national shortage of lidocaine, we hope to find a suitable alternative to lidocaine for topical analgesia when placing arterial lines and epidurals. Our hypothesis is that the sprays will not affect the sterility of the area. We will compare microbial growth from three subsequent swabs taken from a single area of skin on the wrist and lower back: one with no treatment, the second after treatment with ChloraPrep, and the third after applying one of the numbing sprays. If there is significantly higher growth in the swabs containing the topical anesthetic spray versus the ChloraPrep alone, this will indicate that the sprays introduce microbes to the sites of skin.

Full description

The purpose of this study is to determine whether Gebauer's Pain Ease and Ethyl Chloride topical anesthetic sprays are safe for application on the areas of skin where epidurals (lower back) and arterial lines (wrist) are placed, based on whether they introduce microbial growth to these areas. The investigators will compare microbial growth by swabbing both of these skin sites following: 1) no treatment 2) ChloraPrep treatment and 3) ChloraPrep plus numbing spray (Ethyl Chloride or Pain Ease) treatment. The cultures will then be incubated to test for anaerobic bacteria, aerobic bacteria, and mold growth. The microbial growth will be compared between the three treatment groups based on the number of colony forming units present.

Funding for the project will be from the manufacturer of the numbing sprays, Gebauer Company.

Based on power analysis, for each of the numbing sprays, a total of 72 subjects must be enrolled, with 6 swabs taken per subject (untreated, ChloraPrep, and topical anesthetic spray samples will be taken from both the wrist and lower back of each subject). A sample size of 72 pairs achieves 80 % power to detect an odds ratio of 24 using a two-sided McNemar test with a significance level of 0.05.

Enrollment

72 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Henry Ford employees

Exclusion criteria

People with infections at the site of prep
People with history of hypersensitivity to numbing sprays or chloraprep

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 4 patient groups

Microbial growth on wrist after application of Gebauer's Ethyl Chloride

Experimental group

Description:

An area of skin on the wrist will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present.

Treatment:

Drug: Gebauer's Ethyl Chloride

Microbial growth on lower back after application of Gebauer's Ethyl Chloride

Experimental group

Description:

An area of skin on the lower back will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present.

Treatment:

Drug: Gebauer's Ethyl Chloride

Microbial growth on wrist after application of Gebauer's Pain Ease

Experimental group

Description:

An area of skin on the wrist will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Pain Ease topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present.

Treatment:

Drug: Gebauer's Pain Ease Top Aerosol Mist Spray

Microbial growth on lower back after application of Gebauer's Pain Ease

Experimental group

Description:

An area of skin on the lower back will be swabbed before and after Chloraprep application, and then each area will be swabbed again after application of Gebauer's Pain Ease topical refrigerant spray. The bacterial growth prior to and after numbing spray application will be evaluated, based on the number of colony forming units that are present.

Treatment:

Drug: Gebauer's Pain Ease Top Aerosol Mist Spray

Trial documents