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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

September 27, 2012
December 11, 2015
October 2012
November 2013   (final data collection date for primary outcome measure)
Analgesic Effect [ Time Frame: At postoperative day 5 ] [ Designated as safety issue: No ]
Total cumulative dose of morphine equivalent narcotics.
Same as current
Complete list of historical versions of study NCT01700491 on ClinicalTrials.gov Archive Site
Hypotension [ Time Frame: At postoperative day 5 ] [ Designated as safety issue: Yes ]
Cumulative time in which the systolic blood pressure is below 90mmHg.
Same as current
Not Provided
Not Provided
 
Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy
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
Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior to epidural analgesia in terms of the main complication of hypotension.
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypotension
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01700491
B2012:038
No
Not Provided
Not Provided
Sadeesh Srinathan, MD, University of Manitoba
University of Manitoba
Not Provided
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
University of Manitoba
December 2015

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