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

This study has been terminated.
(Difficulty in recruiting and maintenance of blinding necessary for the trial)
Sponsor:
Information provided by (Responsible Party):
Sadeesh Srinathan, MD, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01700491
First received: September 27, 2012
Last updated: December 11, 2015
Last verified: December 2015
  Purpose
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 Intervention Phase
Hypotension
Drug: Epidural Catheter 0.2% ropivacaine
Drug: Paravertebral Catheter 0.4% ropivacaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Analgesic Effect [ Time Frame: At postoperative day 5 ] [ Designated as safety issue: No ]
    Total cumulative dose of morphine equivalent narcotics.


Secondary Outcome Measures:
  • Hypotension [ Time Frame: At postoperative day 5 ] [ Designated as safety issue: Yes ]
    Cumulative time in which the systolic blood pressure is below 90mmHg.


Enrollment: 21
Study Start Date: October 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: September 27, 2012
Last Updated: December 11, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on August 24, 2016