Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain

Study Overview
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Brief Summary
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We will compare thoracic epidural anesthesia which is presently used for management of pain after thoracotomy to an intra-operatively placed extrapleural intercostal catheter. The study wil be double blinded and prospective.

Detailed Description
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The aim of this study is to evaluate the efficacy of thoracic epidural vs. continuous extra-pleural intercostal local anesthesia for the treatment of post thoracotomy pain in adult patients. Study patients will be randomized between the thoracic epidural and continuous extrapleural catheter groups[Figure 1]. Because thoracic epidural anesthesia is the gold standard but continuous extrapleural intercostal local anesthesia is potentially easier and less prone to complications, the study will be structured as an equivalence study. The null hypothesis (Ho) is that continuous intercostal nerve blockade is worse than epidural for post-thoracotomy pain management. Therefore, the alternative hypothesis (Ha) is then that continuous intercostal nerve blockade is equal to or better than epidural for post-thoracotomy pain management.

Official Title
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A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain

Conditions
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THoracotomy

Intervention / Treatment
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* Procedure: Thoracic Epidural
* Procedure: Extrapleural Intercostal Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral thoracotomy Video Assisted thoracotomy with high likely hood of converting to open thoracotmoy Exclusion Criteria: Bilateral thoracotomy Planned bilateral thoracotomy Planned chest wall resection Planned combined thoracotomy and laparotomy procedure VATS procedure without conversion to unilateral thoracotomy Emergency operation Critically ill patients Patients who require an assistive device (i.e. cane, walker, or wheel chair) for mobility Patients who are unable to give informed consent Patients with preoperative chronic back or chest wall pain Empyema or other infective condition increasing the risk of epidural infection Coagulopathy Decision of the surgeon or anesthesiologist, or choice of the patient Infection at site of epidural placement Patients with other co morbidities which exclude thoracic epidural placement Patients under the age of 18 years

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous extra-pleural intercostal local anesthesia<br>intra-operatively placed extrapleural intercostal catheter | Procedure: Extrapleural Intercostal Catheter<br>* Continuous extra-pleural intercostal local anesthesia<br>|
| Active Comparator: Thoracic Epidural<br>gold standard | Procedure: Thoracic Epidural<br>* Gold standard for post thoracotomy pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain control-visual analog pain score |  | post surgery monitoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities |  | post surgery monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THoracic Surgery, thoracic epidural, epidural, thoracotomy, intercostal nerve block, intercostal, nerve block