Perioperative Epidural Trial (POET) Pilot Study

Post Operative Pain Control Clinical Trial

Official title:

Perioperative Epidural Trial (POET) Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221260
• Other study ID #: C04-0078
• Secondary ID: 04-3046
• Status: Completed
• Phase: N/A
• First received: September 18, 2005
• Last updated: September 24, 2008
• Start date: September 2005
• Est. completion date: January 2008

Study information

• Verified date: September 2008
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Contraindication to epidural anesthesia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain Control

Intervention

Procedure:
• anesthesia
Intraoperative general anesthesia AND postoperative IV narcotic analgesia.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital, Clinical Health Research Unit	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure		Unspecified	No
Secondary	DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension		Unspecified	No