Do Epidurals Placed at a Lower Level Improve Labor Analgesia?

Labor Analgesia Clinical Trial

Official title:

Do Epidurals Placed at a Lower Level Improve Labour Analgesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00954317
• Other study ID #: SDR-08-052
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2009
• Last updated: November 29, 2012
• Start date: September 2009
• Est. completion date: January 2014

Study information

• Verified date: November 2012
• Source: Royal Victoria Hospital, Canada
• Contact: albert r moore, md
• Phone: 514.934.1934
• Email: moore_albert[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Analgesia

Intervention

Procedure:
• epidural placed low
epidural placed low
• high epidural
high epidural

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Royal Victoria Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of epidural medication boluses required		30 minutes and 1 hour	No
Secondary	Labour progress		24 hours	No