Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hypotension

Intervention / Treatment
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* Drug: Epidural Catheter 0.2% ropivacaine
* Drug: Paravertebral Catheter 0.4% ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural Catheter 0.2% ropivacaine<br>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<br>* 0.2% ropivacaine into epidural space and saline into paravertebral space<br>|
| Active Comparator: Paravertebral Catheter 0.4% ropivacaine<br>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<br>* 0.4% ropivacaine into paravertebral space and saline into the epidural space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic Effect | Total cumulative dose of morphine equivalent narcotics. | At postoperative day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | Cumulative time in which the systolic blood pressure is below 90mmHg. | At postoperative day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia,Epidural, Analgesia,Paravertebral, Paravertebral Catheter, Epidural Catheter, Analgesia, Hypotension