Aseptic Techniques During Epidural Analgesia in the Labor Floor

Pregnancy Clinical Trial

— EAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235858
• Other study ID #: EAS-2009
• Status: Completed
• Phase: N/A
• First received: September 27, 2010
• Last updated: April 3, 2012
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2011
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy

Intervention

Procedure:
• wearing of sterile gowns
Anesthesiologists wearing sterile gown for epidural insertion
• No gown
Anesthesiologists not wearing sterile gown for epidural insertion

Locations

Country	Name	City	State
Canada	Department of Anesthesia Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	length of epidural catheterization and positive culture		one year and a half	Yes