We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764932
First Posted: January 10, 2013
Last Update Posted: September 14, 2017
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.
Information provided by (Responsible Party):
Kenneth D Candido, Chicago Anesthesia Pain Specialists
  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: 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


Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: November 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


Locations
United States, Illinois
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
Sponsors and Collaborators
Chicago Anesthesia Pain Specialists
Investigators
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
ClinicalTrials.gov Identifier: NCT01764932     History of Changes
Other Study ID Numbers: Advocate-IRB-5242
First Submitted: January 2, 2013
First Posted: January 10, 2013
Last Update Posted: September 14, 2017
Last Verified: September 2017