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

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ClinicalTrials.gov Identifier: NCT01700491
Recruitment Status : Terminated (Difficulty in recruiting and maintenance of blinding necessary for the trial)
First Posted : October 4, 2012
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Sadeesh Srinathan, MD, University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Hypotension Drug: Epidural Catheter 0.2% ropivacaine Drug: Paravertebral Catheter 0.4% ropivacaine Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Epidural Catheter 0.2% ropivacaine
0.2% ropivacaine into epidural space and saline into paravertebral space

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




Primary Outcome Measures :
  1. Analgesic Effect [ Time Frame: At postoperative day 5 ]
    Total cumulative dose of morphine equivalent narcotics.


Secondary Outcome Measures :
  1. Hypotension [ Time Frame: At postoperative day 5 ]
    Cumulative time in which the systolic blood pressure is below 90mmHg.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700491


Locations
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9
Sponsors and Collaborators
University of Manitoba
Investigators
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

Responsible Party: Sadeesh Srinathan, MD, Assistant Professor- Department of Thoracic Surgery, University of Manitoba
ClinicalTrials.gov Identifier: NCT01700491     History of Changes
Other Study ID Numbers: B2012:038
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Sadeesh Srinathan, MD, University of Manitoba:
Paravertebral Catheter
Epidural Catheter
Analgesia
Hypotension
Analgesia,Epidural
Analgesia,Paravertebral

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents