A Phase 1 interventional study of Thoracic Epidural and Extrapleural Intercostal Catheter in THoracotomy, sponsored by Virginia Commonwealth University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-15.
Sponsored by Virginia Commonwealth University · Phase 1, Interventional, and Health services research
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.
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.
Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 82 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
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Exclusion Criteria:
intra-operatively placed extrapleural intercostal catheter
Procedure: Extrapleural Intercostal Catheter
gold standard
Procedure: Thoracic Epidural
Gold standard for post thoracotomy pain
Continuous extra-pleural intercostal local anesthesia
pain control-visual analog pain score
Time frame: post surgery monitoring
respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities
Time frame: post surgery monitoring
This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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