Post Operative Pain ControlNCT00221260
Perioperative Epidural Trial (POET) Pilot Study
A study testing anesthesia in people with Post Operative Pain Control, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Post Operative Pain Control
- What is being tested?
- anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects at high risk of cardio-respiratory complications post operatively.
Who cannot join
- Contraindication to epidural anesthesia
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital, Clinical Health Research Unit
Vancouver, British Columbia, V5Z 1L8
About this study
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
- Conditions
- Post Operative Pain Control
- Being tested
- anesthesia
- Keywords
- Analgesia, anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesiaProcedure or surgery
Intraoperative general anesthesia AND postoperative IV narcotic analgesia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure
Secondary outcomes (1)
DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pain ControlStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Peter Choi, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221260
- Sponsor's protocol ID
- C04-0078
- Other IDs
- 04-3046
- Status last verified
- Sep 2008
- First submitted
- 18 Sep 2005
- Last updated
- 25 Sep 2008
- Results posted
- No
Publications
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.
PubMed 19247497
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Epidural Trial (POET) Pilot Study
- ClinicalTrials.gov ID
- NCT00221260
- Acronym / sponsor ID
- C04-0078
- Conditions
- Post Operative Pain Control
- Keywords
- Analgesia, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects at high risk of cardio-respiratory complications post operatively.
Key exclusion criteria (1 listed)
- Contraindication to epidural anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anesthesiaIntraoperative general anesthesia AND postoperative IV narcotic analgesia. | Procedure or surgery | – |
Primary outcome
Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure
1 secondary outcome
DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2008.
- Derived from this study: PubMed 19247497Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Choi, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anesthesia in people with Post Operative Pain Control, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2008.