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
|Condition or disease||Intervention/treatment||Phase|
|Hypotension||Drug: Epidural Catheter 0.2% ropivacaine Drug: Paravertebral Catheter 0.4% ropivacaine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- Analgesic Effect [ Time Frame: At postoperative day 5 ]Total cumulative dose of morphine equivalent narcotics.
- Hypotension [ Time Frame: At postoperative day 5 ]Cumulative time in which the systolic blood pressure is below 90mmHg.
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
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A1R9|
|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|