NCT00954317

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

4.3 years

First QC Date

August 5, 2009

Last Update Submit

November 29, 2012

Conditions

Labor Analgesia

Keywords

epidurallabour analgesia

Outcome Measures

Primary Outcomes (1)

  • Number of epidural medication boluses required

    30 minutes and 1 hour

Secondary Outcomes (1)

  • Labour progress

    24 hours

Study Arms (2)

Low epidural

ACTIVE COMPARATOR

epidural placed in the lower lumbar vertebral column

Procedure: epidural placed low

high epidural

EXPERIMENTAL

high epidural

Procedure: high epidural

Interventions

epidural placed lowPROCEDURE

epidural placed low

Low epidural
high epiduralPROCEDURE

high epidural

high epidural

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women in active labor

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28504988DERIVED

Central Study Contacts

albert r moore, md

CONTACT

514.934.1934moore_albert@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 7, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

November 30, 2012

Record last verified: 2012-11

Locations

CA(1)