Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging

This study is currently recruiting participants.
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
  Purpose

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: Open Label
Primary Purpose: Treatment
Official Title: Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging

Further study details as provided by Chicago Anesthesia Pain Specialists:

Primary Outcome Measures:
  • Presumed intervertebral level of epidural catheter [ Time Frame: During procedure ] [ Designated as safety issue: No ]
    At the time of thoracic epidural catheter insertion


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • Patient satisfaction [ Time Frame: Post procedure at 48 hours ] [ Designated as safety issue: No ]
    Patient satisfaction 48 hrs after the end of surgery


Estimated Enrollment: 60
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764932

Contacts
Contact: N. Nick Knezevic, M.D., Ph.D. 773-296-7927 aimmc.anesthesia.research@gmail.com

Locations
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    aimmc.anesthesia.research@gmail.com   
Principal Investigator: Kenneth D Candido, M.D.         
Sponsors and Collaborators
Chicago Anesthesia Pain Specialists
Investigators
Principal Investigator: Kenneth D Candido, M.D. Chicago Anesthesia Pain Specialists
  More Information

No publications provided

Responsible Party: Kenneth D Candido, Chairman of the Anesthesia Department, Advocate Illinois Masonic Medical Center, Chicago Anesthesia Pain Specialists
ClinicalTrials.gov Identifier: NCT01764932     History of Changes
Other Study ID Numbers: Advocate-IRB-5242
Study First Received: January 2, 2013
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 14, 2014