Aseptic Techniques During Epidural Analgesia in the Labor Floor

Study Overview
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Brief Summary
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There is an increasing trend in the incidence of infection related to epidural anesthesia. This could be related to methods of aseptic technique as adopted by the anesthesiologist during the performance of the procedure. The purpose of this study is to compare two methods of aseptic technique for labor epidural insertion; a conventional method without wearing a sterile gown (free from living germs or microorganisms) versus strict aseptic method with wearing of sterile gowns. It is our belief that there will be an increased contamination of epidural equipment and colonization of epidural catheter, secondary to bacterial fallout from the operators' bare hands in the group not wearing the sterile gowns.

Detailed Description
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At the present time there is no accepted standard for aseptic technique during insertion of an epidural catheter on the labor floor and what is considered to be essential is controversial. Recognizing this, the American Society of Regional Anesthesia (ASRA), the leading authority on regional anesthesia, established a task force to examine and establish guidelines for aseptic practice. Their findings highlighted the lack of good quality studies to support specific recommendations. This is especially true in regards to the use of sterile gowns during the performance of the procedure.

Official Title
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Responding to the ASRA (American Society of Regional Anesthesia) Challenge - Should Gowning be the Standard of Practice for Epidural Anesthesia: A Randomized Control Trial

Conditions
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Pregnancy

Intervention / Treatment
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* Procedure: wearing of sterile gowns
* Procedure: No gown


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All pregnant women requesting epidural analgesia Exclusion Criteria: Patients who have fever requiring antibiotics Patients who have received antibiotics in or within the previous 48 hours of labor Immuno-compromised patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Gown group<br>Anesthesiologists wearing sterile gown for epidural insertion | Procedure: wearing of sterile gowns<br>* Anesthesiologists wearing sterile gown for epidural insertion<br>* Other names: Sterile gowns;|
| Other: No Gown group<br>Anesthesiologists not wearing gown for epidural insertion | Procedure: No gown<br>* Anesthesiologists not wearing sterile gown for epidural insertion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth of microbial organisms on operators forearm, agar plate (working area) and proximal and distal tip of the epidural catheter. |  | one and one half year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of epidural catheterization and positive culture |  | one year and a half | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural analgesia, Epidural anesthesia labor, Aseptic technique, gown, no gown