Do Epidurals Placed at a Lower Level Improve Labor Analgesia?

November 29, 2012 updated by: Albert Moore, Royal Victoria Hospital, Canada

Do Epidurals Placed at a Lower Level Improve Labour Analgesia

The investigators wish to compare the analgesia provided by epidurals placed high in the lumbar spine versus epidurals place low in the lumbar spine.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Procedure: high epidural
high epidural

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of epidural medication boluses required
Time Frame: 30 minutes and 1 hour
30 minutes and 1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Labour progress
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Victoria Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (Estimate)

August 7, 2009

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 29, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDR-08-052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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