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Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy

NCT ID: NCT01700491

Last Updated: 2015-12-15

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Hypotension

Keywords

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Paravertebral Catheter Epidural Catheter Analgesia Hypotension Analgesia,Epidural Analgesia,Paravertebral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Epidural Catheter 0.2% ropivacaine

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.

Group Type ACTIVE_COMPARATOR

Epidural Catheter 0.2% ropivacaine

Intervention Type DRUG

0.2% ropivacaine into epidural space and saline into paravertebral space

Paravertebral Catheter 0.4% ropivacaine

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.

Group Type ACTIVE_COMPARATOR

Paravertebral Catheter 0.4% ropivacaine

Intervention Type DRUG

0.4% ropivacaine into paravertebral space and saline into the epidural space

Interventions

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Epidural Catheter 0.2% ropivacaine

0.2% ropivacaine into epidural space and saline into paravertebral space

Intervention Type DRUG

Paravertebral Catheter 0.4% ropivacaine

0.4% ropivacaine into paravertebral space and saline into the epidural space

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Sadeesh Srinathan, MD

Assistant Professor- Department of Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sadeesh Srinathan, MD, FRCS C-Th, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Stephen Kowalski, MD, FRCP

Role: STUDY_CHAIR

University of Manitoba

Rob Brown, MD, FRCP

Role: STUDY_DIRECTOR

University of Manitoba

Purnima Rao, MD

Role: STUDY_DIRECTOR

University of Manitoba

Locations

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Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status

Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2012:038

Identifier Type: -

Identifier Source: org_study_id