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Difficulty in recruiting and maintenance of blinding necessary for the trial
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Catheter 0.2% ropivacaine | Active Comparator | 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. |
|
| Paravertebral Catheter 0.4% ropivacaine | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Catheter 0.2% ropivacaine | Drug | 0.2% ropivacaine into epidural space and saline into paravertebral space |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Effect | Total cumulative dose of morphine equivalent narcotics. | At postoperative day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension | Cumulative time in which the systolic blood pressure is below 90mmHg. | At postoperative day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sadeesh Srinathan, MD, FRCS C-Th, FRCS(C) | University of Manitoba | Principal Investigator |
| Stephen Kowalski, MD, FRCP | University of Manitoba | Study Chair |
| Rob Brown, MD, FRCP | University of Manitoba | Study Director |
| Purnima Rao, MD | University of Manitoba | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada | ||
| Health Sciences Centre |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Paravertebral Catheter 0.4% ropivacaine | Drug | 0.4% ropivacaine into paravertebral space and saline into the epidural space |
|
| Winnipeg |
| Manitoba |
| R3A1R9 |
| Canada |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |