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Aseptic Techniques During Epidural Analgesia in the Labor Floor

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01235858
Acronym
EAS
Enrollment
240
Registered
2010-11-08
Start date
2009-11-30
Completion date
2011-12-31
Last updated
2012-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Epidural analgesia, Epidural anesthesia labor, Aseptic technique, gown, no gown

Brief summary

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

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.

Interventions

PROCEDUREwearing of sterile gowns

Anesthesiologists wearing sterile gown for epidural insertion

PROCEDURENo gown

Anesthesiologists not wearing sterile gown for epidural insertion

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
length of epidural catheterization and positive cultureone year and a half

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026