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. Identifier: NCT01764932
Recruitment Status : Active, not recruiting
First Posted : January 10, 2013
Last Update Posted : September 14, 2017
Information provided by (Responsible Party):
Kenneth D Candido, Chicago Anesthesia Pain Specialists

January 2, 2013
January 10, 2013
September 14, 2017
December 2011
November 2018   (Final data collection date for primary outcome measure)
Presumed intervertebral level of epidural catheter [ Time Frame: During procedure ]
At the time of thoracic epidural catheter insertion
Same as current
Complete list of historical versions of study NCT01764932 on Archive Site
  • 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.
Same as current
Patient satisfaction [ Time Frame: Post procedure at 48 hours ]
Patient satisfaction 48 hrs after the end of surgery
Same as current
Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging
Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory 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.

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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Patients Undergoing Thoracic Surgery
  • Patients Undergoing 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 catheter insertion
Fluoroscopic imaging. For patients undergoing thoracic epidural analgesia (TEA) with catheter placement for pain associated with thoracic or upper abdominal surgery
Intervention: Procedure: Fluoroscopic imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
December 2018
November 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18- 80 years old patients
  • Patients undergoing thoracic surgery
  • Patients undergoing upper abdominal surgery

Exclusion Criteria:

  • Severe Aortic Valve stenosis
  • Active Neurologic Disease
  • Allergy to lidocaine or bupivacaine
  • Allergy to iodine-based contrast
  • Cutaneous Disorders at epidural insertion site
  • Preoperative impaired coagulation status
  • Pregnancy
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Kenneth D Candido, Chicago Anesthesia Pain Specialists
Chicago Anesthesia Pain Specialists
Not Provided
Principal Investigator: Kenneth D Candido, M.D. Chicago Anesthesia Pain Specialists
Chicago Anesthesia Pain Specialists
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP