Viewing Study NCT01764932


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Study NCT ID: NCT01764932
Status: UNKNOWN
Last Update Posted: 2017-09-14
First Post: 2013-01-02
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging
Sponsor: Chicago Anesthesia Pain Specialists
Organization:

Study Overview

Official Title: Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging
Status: UNKNOWN
Status Verified Date: 2017-09
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will determine the accuracy of the epidural catheter placement by using fluoroscopic imaging.

Previous studies have drawn contradictory conclusions based the potential flaw assumption of 100% success rate for correct epidural catheter placement in the thoracic region.
Detailed Description: Thoracic epidural analgesia (TEA) is a key tool in management of pain after thoracic or upper abdominal surgery. TEA optimizes pain relief while minimizing the use of systemic opioids, thus reducing the duration of postoperative ileus. TEA also attenuates surgical stress response and allows for early mobilization. Despite all the touted benefits of TEA, much controversy limits its use for post surgical pain due to fear of exceedingly rare, if not entirely theoretical complication of epidural hematoma.

Beneficial effects of TEA require that catheter placement and infusate be targeted at the thoracic segments innervating injured skin, muscle, and bone from which pain input originates. The purpose of this study is to determine the accuracy of thoracic epidural continuous catheter insertion by using fluoroscopic imaging.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: