Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01764932|
Recruitment Status : Active, not recruiting
First Posted : January 10, 2013
Last Update Posted : September 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients Undergoing Thoracic Surgery Patients Undergoing Upper Abdominal Surgery||Procedure: Fluoroscopic imaging||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||December 2018|
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.
- Presumed intervertebral level of epidural catheter [ Time Frame: During procedure ]At the time of thoracic epidural catheter insertion
- Radiologic confirmation of epidural catheter placement [ Time Frame: Post procedure within one week. ]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 ]1, 24, and 48 hrs after the end of the surgery.
- Patient satisfaction [ Time Frame: Post procedure at 48 hours ]Patient satisfaction 48 hrs after the end of surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764932
|United States, Illinois|
|Advocate Illinois Masonic Medical Center|
|Chicago, Illinois, United States, 60657|
|Principal Investigator:||Kenneth D Candido, M.D.||Chicago Anesthesia Pain Specialists|