Do Epidurals Placed at a Lower Level Improve Labor Analgesia?
Primary Purpose
Labor Analgesia
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
epidural placed low
high epidural
Sponsored by
About this trial
This is an interventional treatment trial for Labor Analgesia focused on measuring epidural, labour analgesia
Eligibility Criteria
Inclusion Criteria:
- women in active labor
Exclusion Criteria:
- known contraindications to epidural analgesia
- moderate to severe systemic illness as evidenced by an American Society of Anesthesiologists (ASA) score of 3 or higher.
- known abnormalities of the spinal column
- any neurologic illness
- multiple gestations, fetal abnormalities or fetal presentation other than vertex
- recent history of analgesic usage
- an inability to communicate in English or French
- Body Mass Index greater than 40
- patients in pain requesting an immediate epidural
Sites / Locations
- Royal Victoria HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Low epidural
high epidural
Arm Description
epidural placed in the lower lumbar vertebral column
high epidural
Outcomes
Primary Outcome Measures
Number of epidural medication boluses required
Secondary Outcome Measures
Labour progress
Full Information
NCT ID
NCT00954317
First Posted
August 5, 2009
Last Updated
November 29, 2012
Sponsor
Royal Victoria Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00954317
Brief Title
Do Epidurals Placed at a Lower Level Improve Labor Analgesia?
Official Title
Do Epidurals Placed at a Lower Level Improve Labour Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Victoria Hospital, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators wish to compare the analgesia provided by epidurals placed high in the lumbar spine versus epidurals place low in the lumbar spine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Analgesia
Keywords
epidural, labour analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low epidural
Arm Type
Active Comparator
Arm Description
epidural placed in the lower lumbar vertebral column
Arm Title
high epidural
Arm Type
Experimental
Arm Description
high epidural
Intervention Type
Procedure
Intervention Name(s)
epidural placed low
Intervention Description
epidural placed low
Intervention Type
Procedure
Intervention Name(s)
high epidural
Intervention Description
high epidural
Primary Outcome Measure Information:
Title
Number of epidural medication boluses required
Time Frame
30 minutes and 1 hour
Secondary Outcome Measure Information:
Title
Labour progress
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women in active labor
Exclusion Criteria:
known contraindications to epidural analgesia
moderate to severe systemic illness as evidenced by an American Society of Anesthesiologists (ASA) score of 3 or higher.
known abnormalities of the spinal column
any neurologic illness
multiple gestations, fetal abnormalities or fetal presentation other than vertex
recent history of analgesic usage
an inability to communicate in English or French
Body Mass Index greater than 40
patients in pain requesting an immediate epidural
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
albert r moore, md
Phone
514.934.1934
Ext
34880
Email
moore_albert@hotmail.com
Facility Information:
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
albert r moore, md
12. IPD Sharing Statement
Citations:
PubMed Identifier
28504988
Citation
Moore A, Villeneuve V, Bravim B, El-Bahrawy A, El-Mouallem E, Kaufman I, Hatzakorzian R, Li Pi Shan W. The Labor Analgesia Requirements in Nulliparous Women Randomized to Epidural Catheter Placement in a High or Low Intervertebral Space. Anesth Analg. 2017 Dec;125(6):1969-1974. doi: 10.1213/ANE.0000000000002076.
Results Reference
derived
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Do Epidurals Placed at a Lower Level Improve Labor Analgesia?
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