Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373633
Status:
TERMINATED
Last Update Posted:
2014-08-15
First Post:
2006-09-06
Brief Title:
Extrapleural Intercostal Catheter vs Thoracic Epidural for Thoracotomy Pain
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain
Status:
TERMINATED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated due to diminishing frequency of thorocotomies and slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 groupsFigure 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None