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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235858
First Posted: November 8, 2010
Last Update Posted: April 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
  Purpose

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.


Condition Intervention
Pregnancy Procedure: wearing of sterile gowns Procedure: No gown

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • length of epidural catheterization and positive culture [ Time Frame: one year and a half ]

Enrollment: 240
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gown group
Anesthesiologists wearing sterile gown for epidural insertion
Procedure: wearing of sterile gowns
Anesthesiologists wearing sterile gown for epidural insertion
Other Name: Sterile gowns
No Gown group
Anesthesiologists not wearing gown for epidural insertion
Procedure: No gown
Anesthesiologists not wearing sterile gown for epidural insertion

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235858


Locations
Canada, Ontario
Department of Anesthesia Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Naveed Siddiqui, Principal Investigator, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01235858     History of Changes
Other Study ID Numbers: EAS-2009
First Submitted: September 27, 2010
First Posted: November 8, 2010
Last Update Posted: April 4, 2012
Last Verified: July 2011

Keywords provided by Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Epidural analgesia
Epidural anesthesia labor
Aseptic technique
gown
no gown