Do Epidurals Placed at a Lower Level Improve Labor Analgesia?

NCT ID: NCT00954317

Last Updated: 2012-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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Conditions

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Labor Analgesia

Keywords

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epidural labour analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low epidural

epidural placed in the lower lumbar vertebral column

Group Type ACTIVE_COMPARATOR

epidural placed low

Intervention Type PROCEDURE

epidural placed low

high epidural

high epidural

Group Type EXPERIMENTAL

high epidural

Intervention Type PROCEDURE

high epidural

Interventions

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epidural placed low

epidural placed low

Intervention Type PROCEDURE

high epidural

high epidural

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Victoria Hospital, Canada

OTHER

Sponsor Role lead

Responsible Party

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Albert Moore

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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albert r moore, md

Role: CONTACT

Phone: 514.934.1934

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 28504988 (View on PubMed)

Other Identifiers

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SDR-08-052

Identifier Type: -

Identifier Source: org_study_id