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

This study is currently recruiting participants.

Verified February 2013 by University of Manitoba

Sponsor:

Collaborators:

Department of Anesthesia and Perioperative Medicine

Department of Surgery

Information provided by (Responsible Party):

Sadeesh Srinathan, MD, University of Manitoba

ClinicalTrials.gov Identifier:

NCT01700491

First received: September 27, 2012

Last updated: February 12, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2012

Last Updated Date

February 12, 2013

Start Date ^ICMJE

October 2012

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Analgesic Effect [ Time Frame: At postoperative day 5 ] [ Designated as safety issue: No ]

Total cumulative dose of morphine equivalent narcotics.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01700491 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hypotension [ Time Frame: At postoperative day 5 ] [ Designated as safety issue: Yes ]

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hypotension

Intervention ^ICMJE

Drug: Epidural Catheter 0.2% ropivacaine
0.2% ropivacaine into epidural space and saline into paravertebral space
Drug: Paravertebral Catheter 0.4% ropivacaine
0.4% ropivacaine into paravertebral space and saline into the epidural space

Study Arm (s)

Active Comparator: 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.

Intervention: Drug: Epidural Catheter 0.2% ropivacaine
Active Comparator: 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.

Intervention: Drug: Paravertebral Catheter 0.4% ropivacaine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2013

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Sadeesh Srinathan, Medicine	(204) 787-7143	ssrinathan@gmail.com
Contact: Purnima Rao, Medicine	(204) 688-6309	umrao@cc.umanitoba.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01700491

Other Study ID Numbers ^ICMJE

B2012:038

Has Data Monitoring Committee

Responsible Party

Sadeesh Srinathan, MD, University of Manitoba

Study Sponsor ^ICMJE

University of Manitoba

Collaborators ^ICMJE

Department of Anesthesia and Perioperative Medicine
Department of Surgery

Investigators ^ICMJE

Principal Investigator:	Sadeesh Srinathan, MD, FRCS C-Th, FRCS(C)	University of Manitoba
Study Chair:	Stephen Kowalski, MD, FRCP	University of Manitoba
Study Director:	Rob Brown, MD, FRCP	University of Manitoba
Study Director:	Purnima Rao, MD	University of Manitoba

Information Provided By

University of Manitoba

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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