A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- THoracotomy
- Sponsor
- Virginia Commonwealth University
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- pain control-visual analog pain score
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
pain control-visual analog pain score
Time Frame: post surgery monitoring
Secondary Outcomes
- respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities(post surgery monitoring)