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

March 1, 2024 updated by: Katherine Nowak, PhD, Henry Ford Health System

Study to Determine the Safety of Gebauer's Ethyl Chloride and Gebauer's Pain Ease Sprays When Used Following ChloraPrep for Invasive Procedures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

72

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 Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microbial growth on wrist after application of Gebauer's Ethyl Chloride
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.
Drug: Gebauer's Ethyl Chloride
Topical refrigerant spray
Other Names:
  • Ethyl Chloride
Experimental: Microbial growth on lower back after application of Gebauer's Ethyl Chloride
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.
Drug: Gebauer's Ethyl Chloride
Topical refrigerant spray
Other Names:
  • Ethyl Chloride
Experimental: Microbial growth on wrist after application of Gebauer's Pain Ease
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.
Drug: Gebauer's Pain Ease Top Aerosol Mist Spray
Topical refrigerant spray
Other Names:
  • Pain Ease
Experimental: Microbial growth on lower back after application of Gebauer's Pain Ease
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.
Drug: Gebauer's Pain Ease Top Aerosol Mist Spray
Topical refrigerant spray
Other Names:
  • Pain Ease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Microbial Growth (1+ CFU)
Time Frame: Skin samples were swabbed within 20 seconds of Ethyl Chloride or Pain Ease application, and then swabs were cultured for 3 days before checking for the presence of CFU.
Number of skin samples that were positive for bacterial growth following treatment with ChloraPrep and then application of a topical refrigerant spray (Gebauer's Ethyl Chloride or Gebauer's Pain Ease), when the area was swabbed and cultured for three days. A sample was considered positive if 1 or more colony forming units were present per swab.
Skin samples were swabbed within 20 seconds of Ethyl Chloride or Pain Ease application, and then swabs were cultured for 3 days before checking for the presence of CFU.

Collaborators and Investigators

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

Sponsor

Henry Ford Health System

Collaborators

Gebauer Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 26, 2021

Primary Completion (Actual)

February 25, 2022

Study Completion (Actual)

February 25, 2022

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12932

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Pain

Clinical Trials on Gebauer's Ethyl Chloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe