Do Epidurals Placed at a Lower Level Improve Labor Analgesia?

• Sponsor: Royal Victoria Hospital, Canada (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00954317
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 52
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Analgesia	Procedure: epidural placed low; Procedure: high epidural	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Do Epidurals Placed at a Lower Level Improve Labour Analgesia
• Study Start Date: Sep 1, 2009
• Anticipated Primary Completion Date: Jan 1, 2014
• Anticipated Study Completion Date: Jan 1, 2014

Arms and Interventions

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 high epidural	Procedure: high epidural; high epidural

Outcome Measures

Primary Outcome Measures

1. Number of epidural medication boluses required [30 minutes and 1 hour]

Secondary Outcome Measures

1. Labour progress [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Royal Victoria Hospital	Montreal	Quebec	Canada	H3A 1A1

Sponsors and Collaborators

• Royal Victoria Hospital, Canada

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Albert Moore, Dr., Royal Victoria Hospital, Canada
• ClinicalTrials.gov Identifier: NCT00954317
• Other Study ID Numbers: SDR-08-052
• First Posted: Aug 7, 2009
• Last Update Posted: Nov 30, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Albert Moore, Dr., Royal Victoria Hospital, Canada: epidural; labour analgesia
• Additional relevant MeSH terms: Agnosia

Study Results

No Results Posted as of Nov 30, 2012