Aseptic Techniques During Epidural Analgesia in the Labor Floor (EAS)

April 3, 2012 updated by: Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Department of Anesthesia Mount Sinai 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Gown group
Anesthesiologists wearing sterile gown for epidural insertion
Procedure: wearing of sterile gowns
Anesthesiologists wearing sterile gown for epidural insertion
Other Names:
  • Sterile gowns
Other: No Gown group
Anesthesiologists not wearing gown for epidural insertion
Procedure: No gown
Anesthesiologists not wearing sterile gown for epidural insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one and one half year

Secondary Outcome Measures

Outcome Measure
Time Frame
length of epidural catheterization and positive culture
Time Frame: one year and a half
one year and a half

Collaborators and Investigators

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

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Investigators

  • Principal Investigator: Naveed T Siddiqui, MD, Department of Anesthesia and Pain Management Mount Sinai Hospital, Toronto,Canada

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

November 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (Estimate)

November 7, 2010

Study Record Updates

Last Update Posted (Estimate)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 3, 2012

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EAS-2009

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.

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