A Phase 4 interventional study of Gebauer's Pain Ease Top Aerosol Mist Spray and Gebauer's Ethyl Chloride in Spray, Pain and Safety Issues, sponsored by Henry Ford Health System. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-03-04.
Sponsored by Henry Ford Health System · Phase 4, Interventional, and Treatment
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.
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.
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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
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
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
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
Also known as: Pain Ease
Topical refrigerant spray
Also known as: Ethyl Chloride
Presence of Microbial Growth (1+ 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.
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.
| Milestone | Microbial Growth on Wrists and Lower After Application of Gebauer's Ethyl Chloride or Pain Ease. |
|---|---|
| Started | 72 |
| Left wrist: chloraprep, then gebauer's ethyl chloride | 72 |
| Right wrist: chloraprep, then gebauer's pain ease | 72 |
| Low back: chloraprep, then gebauer's ethyl chloride | 72 |
| Low back: chloraprep, then gebauer's pain ease | 72 |
| Completed | 72 |
| Not completed | 0 |
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.
| Number of samples with 1+ CFU | Wrist, Gebauer's Ethyl Chloride | Lower Back, Gebauer's Ethyl Chloride | Wrist, Gebauer's Pain Ease | Lower Back, Gebauer's Pain Ease |
|---|---|---|---|---|
| Samples with positive growth after application of ChloraPrep followed by topical refrigerant spray | 2 | 1 | 1 | 1 |
| Samples with positive growth after application of ChloraPrep | 1 | 0 | 0 | 2 |
| Samples with positive growth before ChloraPrep treatment (positive control) | 68 | 63 | 65 | 49 |
Collected over During swabbing of skin (5-15 minutes). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Microbial Growth on Wrist After Application of Gebauer's Ethyl Chloride | 0/72 (0%) | 0/72 (0%) | 0/72 (0%) |
| Microbial Growth on Lower Back After Application of Gebauer's Ethyl Chloride | 0/72 (0%) | 0/72 (0%) | 0/72 (0%) |
| Microbial Growth on Wrist After Application of Gebauer's Pain Ease | 0/72 (0%) | 0/72 (0%) | 0/72 (0%) |
| Microbial Growth on Lower Back After Application of Gebauer's Pain Ease | 0/72 (0%) | 0/72 (0%) | 0/72 (0%) |
| Age, Continuous(years) | Microbial Growth on Skin After Application of Gebauer's Ethyl Chloride or Pain Ease |
|---|
| Sex: Female, Male(Participants) | Microbial Growth on Skin After Application of Gebauer's Ethyl Chloride or Pain Ease |
|---|---|
| Female | — |
| Male | — |
| Race and Ethnicity Not Collected(Participants) | Microbial Growth on Skin After Application of Gebauer's Ethyl Chloride or Pain Ease |
|---|
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