Recruiting

Epidurals

Sponsor:

Royal Victoria Hospital, Canada

Code:

NCT00954317

Conditions

Labor Analgesia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

epidural placed low

high epidural

Study Details

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.

Conditions

Labor Analgesia

Study ID

NCT00954317

Start date

Sep, 2009

Status verified date

Nov, 2012

Completion date

Jan, 2014

Anticipated

Primary completion date

Jan, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Low epidural

epidural placed in the lower lumbar vertebral column

experimental: high epidural

high epidural

Interventions

epidural placed low

epidural placed low

high epidural

high epidural

Primary outcome measure

  • Number of epidural medication boluses required [ Time Frame: 30 minutes and 1 hour ]

Central Contacts and Locations

Central contacts

Locations

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Principal Investigator:

albert r moore, md

More Information

Sponsor

Royal Victoria Hospital, Canada

Last update posted

Nov 30, 2012

Last verified

Nov, 2012

Keywords

  • epidural
  • labour analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Royal Victoria Hospital, Canada on 2012-11-30.