Do Epidurals Placed at a Lower Level Improve Labor Analgesia?

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Royal Victoria Hospital, Canada
Sponsor:
Information provided by (Responsible Party):
Albert Moore, Royal Victoria Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00954317
First received: August 5, 2009
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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 Intervention
Labor Analgesia
Procedure: epidural placed low
Procedure: high epidural

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Do Epidurals Placed at a Lower Level Improve Labour Analgesia

Further study details as provided by Royal Victoria Hospital, Canada:

Primary Outcome Measures:
  • Number of epidural medication boluses required [ Time Frame: 30 minutes and 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Labour progress [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954317

Contacts
Contact: albert r moore, md 514.934.1934 ext 34880 moore_albert@hotmail.com

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

No publications provided

Responsible Party: Albert Moore, Dr., Royal Victoria Hospital, Canada
ClinicalTrials.gov Identifier: NCT00954317     History of Changes
Other Study ID Numbers: SDR-08-052
Study First Received: August 5, 2009
Last Updated: November 29, 2012
Health Authority: Canada: Health Canada

Keywords provided by Royal Victoria Hospital, Canada:
epidural
labour analgesia

ClinicalTrials.gov processed this record on July 29, 2014