Back to resultsPerioperative Epidural Trial (POET) Pilot Study
Primary Purpose
Post Operative Pain Control
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain Control focused on measuring Analgesia, anesthesia
Eligibility Criteria
Inclusion Criteria: Subjects at high risk of cardio-respiratory complications post operatively. Exclusion Criteria: Contraindication to epidural anesthesia
Sites / Locations
- Vancouver General Hospital, Clinical Health Research Unit
Outcomes
Primary Outcome Measures
Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure
Secondary Outcome Measures
DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension
Full Information
NCT ID
NCT00221260
First Posted
September 18, 2005
Last Updated
September 24, 2008
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00221260
Brief Title
Perioperative Epidural Trial (POET) Pilot Study
Official Title
Perioperative Epidural Trial (POET) Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain Control
Keywords
Analgesia, anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
anesthesia
Intervention Description
Intraoperative general anesthesia AND postoperative IV narcotic analgesia.
Primary Outcome Measure Information:
Title
Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure
Secondary Outcome Measure Information:
Title
DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects at high risk of cardio-respiratory complications post operatively.
Exclusion Criteria:
Contraindication to epidural anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Choi, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital, Clinical Health Research Unit
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
19247497
Citation
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.
Results Reference
derived
Learn more about this trial
Perioperative Epidural Trial (POET) Pilot Study
We'll reach out to this number within 24 hrs