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Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Kenneth D Candido, Chicago Anesthesia Pain Specialists
Information provided by (Responsible Party):
Kenneth D Candido, Chicago Anesthesia Pain Specialists Identifier:
First received: January 2, 2013
Last updated: August 5, 2016
Last verified: August 2016

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 Intervention
Patients Undergoing Thoracic Surgery Patients Undergoing Upper Abdominal Surgery Procedure: Fluoroscopic imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging

Resource links provided by NLM:

Further study details as provided by Kenneth D Candido, Chicago Anesthesia Pain Specialists:

Primary Outcome Measures:
  • Presumed intervertebral level of epidural catheter [ Time Frame: During procedure ]
    At the time of thoracic epidural catheter insertion

Secondary Outcome Measures:
  • 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.

Other Outcome Measures:
  • Patient satisfaction [ Time Frame: Post procedure at 48 hours ]
    Patient satisfaction 48 hrs after the end of surgery

Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01764932

Contact: N. Nick Knezevic, M.D., Ph.D. 773-296-7927

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   
Principal Investigator: Kenneth D Candido, M.D.         
Sponsors and Collaborators
Chicago Anesthesia Pain Specialists
Principal Investigator: Kenneth D Candido, M.D. Chicago Anesthesia Pain Specialists
  More Information

Responsible Party: Kenneth D Candido, Chairman of the Anesthesia Department, Advocate Illinois Masonic Medical Center, Chicago Anesthesia Pain Specialists Identifier: NCT01764932     History of Changes
Other Study ID Numbers: Advocate-IRB-5242
Study First Received: January 2, 2013
Last Updated: August 5, 2016 processed this record on August 18, 2017