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Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy (ParaEpi)

Primary Purpose

Hypotension

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Epidural Catheter 0.2% ropivacaine
Paravertebral Catheter 0.4% ropivacaine
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring Paravertebral Catheter, Epidural Catheter, Analgesia, Hypotension, Analgesia,Epidural, Analgesia,Paravertebral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Open thoracotomy
  • Age > 18 yo
  • Able to use a patient controlled analgesia device

Exclusion Criteria:

  • Previous thoracotomy
  • Previous spine surgery
  • Chronic pain condition
  • Ongoing narcotic use
  • Prior narcotic abuse
  • Active chest infection
  • Chest trauma
  • Anticoagulation
  • Other contraindication to epidural catheter placement
  • Allergy to local anesthetic or narcotic

Sites / Locations

  • Health Sciences Centre
  • Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Epidural Catheter 0.2% ropivacaine

Paravertebral Catheter 0.4% ropivacaine

Arm Description

Patients will receive an infusion of 0.2% ropivacaine at a range of 0-10 mL/hr through an epidural catheter. They will also receive an infusion of saline at a rate of 0-10 mL/hr through a paravertebral catheter.

Patients will receive an infusion of 0.4% ropivacaine at a range of 0-10mL/hr through a paravertebral catheter. They will also receive an infusion of saline at a range of 0-10mL/hr through an epidural catheter.

Outcomes

Primary Outcome Measures

Analgesic Effect
Total cumulative dose of morphine equivalent narcotics.

Secondary Outcome Measures

Hypotension
Cumulative time in which the systolic blood pressure is below 90mmHg.

Full Information

First Posted
September 27, 2012
Last Updated
December 11, 2015
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01700491
Brief Title
Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy
Acronym
ParaEpi
Official Title
Pilot Study: A Non-Inferiority Trial of the Analgesic Effect of Paravertebral Analgesia to Epidural Analgesia for the Management of Post-Operative Pain After Thoracotomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting and maintenance of blinding necessary for the trial
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior to epidural analgesia in terms of the main complication of hypotension.
Detailed Description
There is some evidence that paravertebral analgesia is similar to epidural analgesia in efficacy but superior in maintenance of blood pressure. This is a double blind, randomized control trial comparing paravertebral catheters to epidural catheters for the management of post thoracotomy analgesia. Both groups will undergo placement of a pre-induction epidural catheter as well as a surgically placed paravertebral catheter. Patients will also receive PCA morphine. The primary outcome will be daily morphine use measured in milligrams. The co-primary outcome will be time spent with a systolic blood pressure below 90mmHg. Outcomes will be measured during the first five postoperative days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Paravertebral Catheter, Epidural Catheter, Analgesia, Hypotension, Analgesia,Epidural, Analgesia,Paravertebral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural Catheter 0.2% ropivacaine
Arm Type
Active Comparator
Arm Description
Patients will receive an infusion of 0.2% ropivacaine at a range of 0-10 mL/hr through an epidural catheter. They will also receive an infusion of saline at a rate of 0-10 mL/hr through a paravertebral catheter.
Arm Title
Paravertebral Catheter 0.4% ropivacaine
Arm Type
Active Comparator
Arm Description
Patients will receive an infusion of 0.4% ropivacaine at a range of 0-10mL/hr through a paravertebral catheter. They will also receive an infusion of saline at a range of 0-10mL/hr through an epidural catheter.
Intervention Type
Drug
Intervention Name(s)
Epidural Catheter 0.2% ropivacaine
Intervention Description
0.2% ropivacaine into epidural space and saline into paravertebral space
Intervention Type
Drug
Intervention Name(s)
Paravertebral Catheter 0.4% ropivacaine
Intervention Description
0.4% ropivacaine into paravertebral space and saline into the epidural space
Primary Outcome Measure Information:
Title
Analgesic Effect
Description
Total cumulative dose of morphine equivalent narcotics.
Time Frame
At postoperative day 5
Secondary Outcome Measure Information:
Title
Hypotension
Description
Cumulative time in which the systolic blood pressure is below 90mmHg.
Time Frame
At postoperative day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Open thoracotomy Age > 18 yo Able to use a patient controlled analgesia device Exclusion Criteria: Previous thoracotomy Previous spine surgery Chronic pain condition Ongoing narcotic use Prior narcotic abuse Active chest infection Chest trauma Anticoagulation Other contraindication to epidural catheter placement Allergy to local anesthetic or narcotic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sadeesh Srinathan, MD, FRCS C-Th, FRCS(C)
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Kowalski, MD, FRCP
Organizational Affiliation
University of Manitoba
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rob Brown, MD, FRCP
Organizational Affiliation
University of Manitoba
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Purnima Rao, MD
Organizational Affiliation
University of Manitoba
Official's Role
Study Director
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A1R9
Country
Canada

12. IPD Sharing Statement

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Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy

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