Clinical trial NCT01235858: Aseptic Techniques During Epidural Analgesia in the Labor Floor
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Epidural analgesia
Epidural anesthesia labor
Aseptic technique
gown
no gown
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2010-11-07
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: Growth of microbial organisms on operators forearm, agar plate (working area) and proximal and distal tip of the epidural catheter.
timeFrame: one and one half year
Secondary outcomes:
measure: length of epidural catheterization and positive culture
timeFrame: one year and a half
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Anesthesia Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Department of Anesthesia and Pain Management Mount Sinai Hospital, Toronto,Canada
name: Naveed T Siddiqui, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.