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Completed

NCT Number: NCT01235858

Aseptic Techniques During Epidural Analgesia in the Labor Floor

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

wearing of sterile gowns

Procedure

Anesthesiologists wearing sterile gown for epidural insertion

Other names: Sterile gowns

No gown

Procedure

Anesthesiologists not wearing sterile gown for epidural insertion

Primary outcomes

  1. Growth of microbial organisms on operators forearm, agar plate (working area) and proximal and distal tip of the epidural catheter.

    Time frame: one and one half year

Secondary outcomes

  1. length of epidural catheterization and positive culture

    Time frame: one year and a half

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

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

Acronym: EAS

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Nov 8, 2010
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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