Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging
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.
Patients Undergoing Thoracic Surgery
Patients Undergoing Upper Abdominal Surgery
Procedure: Fluoroscopic imaging
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging|
- Presumed intervertebral level of epidural catheter [ Time Frame: During procedure ] [ Designated as safety issue: No ]At the time of thoracic epidural catheter insertion
- Radiologic confirmation of epidural catheter placement [ Time Frame: Post procedure within one week. ] [ Designated as safety issue: No ]Radiology department will assess within one week after the procedure the images, to confirm the epidural catheter placement.
- Change in Numeric Rating Pain Score from baseline [ Time Frame: 1, 24 and 48 hrs ] [ Designated as safety issue: No ]1, 24, and 48 hrs after the end of the surgery.
- Patient satisfaction [ Time Frame: Post procedure at 48 hours ] [ Designated as safety issue: No ]Patient satisfaction 48 hrs after the end of surgery
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Thoracic epidural catheter insertion
Fluoroscopic imaging. For patients undergoing thoracic epidural analgesia (TEA) with catheter placement for pain associated with thoracic or upper abdominal surgery
Procedure: Fluoroscopic imaging
Contrast media (5 mL) will be injected through the catheter and fluoroscopic images will be obtained and saved in the lateral and antero-posterior projections.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764932
|Contact: N. Nick Knezevic, M.D., Ph.D.||email@example.com|
|United States, Illinois|
|Advocate Illinois Masonic Medical Center||Recruiting|
|Chicago, Illinois, United States, 60657|
|Contact: N. Nick Knezevic, M.D., Ph.D. 773-296-7927 firstname.lastname@example.org|
|Principal Investigator: Kenneth D Candido, M.D.|
|Principal Investigator:||Kenneth D Candido, M.D.||Chicago Anesthesia Pain Specialists|