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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 January 2013 by Chicago Anesthesia Pain Specialists
Sponsor:
Information provided by (Responsible Party):
Kenneth D Candido, Chicago Anesthesia Pain Specialists
ClinicalTrials.gov Identifier:
NCT01764932
First received: January 2, 2013
Last updated: January 8, 2013
Last verified: January 2013

January 2, 2013
January 8, 2013
December 2011
December 2014   (final data collection date for primary outcome measure)
Presumed intervertebral level of epidural catheter [ Time Frame: During procedure ] [ Designated as safety issue: No ]
At the time of thoracic epidural catheter insertion
Same as current
Complete list of historical versions of study NCT01764932 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Patient satisfaction [ Time Frame: Post procedure at 48 hours ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2015
December 2014   (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
Both
18 Years to 80 Years
No
Contact: N. Nick Knezevic, M.D., Ph.D. 773-296-7927 aimmc.anesthesia.research@gmail.com
United States
 
NCT01764932
Advocate-IRB-5242
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
January 2013

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