Aseptic Techniques During Epidural Analgesia in the Labor Floor
EAS
Responding to the ASRA (American Society of Regional Anesthesia) Challenge - Should Gowning be the Standard of Practice for Epidural Anesthesia: A Randomized Control Trial
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pregnancy
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
November 8, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 4, 2012
July 1, 2011
1 year
September 27, 2010
April 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
length of epidural catheterization and positive culture
one year and a half
Study Arms (2)
Gown group
OTHERAnesthesiologists wearing sterile gown for epidural insertion
No Gown group
OTHERAnesthesiologists not wearing gown for epidural insertion
Interventions
Anesthesiologists wearing sterile gown for epidural insertion
Eligibility Criteria
You may qualify if:
- All pregnant women requesting epidural analgesia
You may not qualify if:
- Patients who have fever requiring antibiotics
- Patients who have received antibiotics in or within the previous 48 hours of labor
- Immuno-compromised patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesia Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Related Publications (1)
Siddiqui NT, Davies S, McGeer A, Carvalho JC, Friedman Z. The effect of gowning on labor epidural catheter colonization rate: a randomized controlled trial. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):520-4. doi: 10.1097/AAP.0000000000000171.
PMID: 25304478DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Naveed T Siddiqui, MD
Department of Anesthesia and Pain Management Mount Sinai Hospital, Toronto,Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 27, 2010
First Posted
November 8, 2010
Study Start
November 1, 2009
Primary Completion
November 1, 2010
Study Completion
December 1, 2011
Last Updated
April 4, 2012
Record last verified: 2011-07