Do Epidurals Placed at a Lower Level Improve Labor Analgesia?

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. Identifier: NCT00954317
Recruitment Status : Unknown
Verified November 2012 by Albert Moore, Royal Victoria Hospital, Canada.
Recruitment status was:  Recruiting
First Posted : August 7, 2009
Last Update Posted : November 30, 2012
Information provided by (Responsible Party):
Albert Moore, Royal Victoria Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Labor Analgesia Procedure: epidural placed low Procedure: high epidural Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Do Epidurals Placed at a Lower Level Improve Labour Analgesia
Study Start Date : September 2009
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Low epidural
epidural placed in the lower lumbar vertebral column
Procedure: epidural placed low
epidural placed low

Experimental: high epidural
high epidural
Procedure: high epidural
high epidural

Primary Outcome Measures :
  1. Number of epidural medication boluses required [ Time Frame: 30 minutes and 1 hour ]

Secondary Outcome Measures :
  1. Labour progress [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00954317

Contact: albert r moore, md 514.934.1934 ext 34880

Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Principal Investigator: albert r moore, md         
Sponsors and Collaborators
Royal Victoria Hospital, Canada

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Albert Moore, Dr., Royal Victoria Hospital, Canada Identifier: NCT00954317     History of Changes
Other Study ID Numbers: SDR-08-052
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: November 2012

Keywords provided by Albert Moore, Royal Victoria Hospital, Canada:
labour analgesia

Additional relevant MeSH terms:
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms