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Perioperative Epidural Trial (POET) Pilot Study

NCT ID: NCT00221260

Last Updated: 2008-09-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-01-31

Brief Summary

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To investigate if the use of perioperative neuraxial blockade reduces post-operative mortality and cardiorespiratory events compared to intraoperative general anesthesia AND postoperative IV narcotic analgesia. This is a feasibility study to determine if recruitment and execution of the protocol could be done in a timely manner in a much larger trial

Detailed Description

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Conditions

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Post Operative Pain Control

Keywords

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Analgesia anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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anesthesia

Intraoperative general anesthesia AND postoperative IV narcotic analgesia.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Subjects at high risk of cardio-respiratory complications post operatively.

Exclusion Criteria

Contraindication to epidural anesthesia
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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University of British Columbia

Principal Investigators

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Peter Choi, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Vancouver General Hospital, Clinical Health Research Unit

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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Choi PT, Beattie WS, Bryson GL, Paul JE, Yang H. Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET) Pilot Study. PLoS One. 2009;4(2):e4644. doi: 10.1371/journal.pone.0004644. Epub 2009 Feb 27.

Reference Type DERIVED
PMID: 19247497 (View on PubMed)

Other Identifiers

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04-3046

Identifier Type: -

Identifier Source: secondary_id

C04-0078

Identifier Type: -

Identifier Source: org_study_id