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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 2, 2013

Last Updated Date

January 8, 2013

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Presumed intervertebral level of epidural catheter [ Time Frame: During procedure ] [ Designated as safety issue: No ]

At the time of thoracic epidural catheter insertion

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01764932 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Patient satisfaction [ Time Frame: Post procedure at 48 hours ] [ Designated as safety issue: No ]

Patient satisfaction 48 hrs after the end of surgery

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging

Official Title ^ICMJE

Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Patients Undergoing Thoracic Surgery
Patients Undergoing Upper Abdominal Surgery

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2015

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: N. Nick Knezevic, M.D., Ph.D.

773-296-7927

aimmc.anesthesia.research@gmail.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01764932

Other Study ID Numbers ^ICMJE

Advocate-IRB-5242

Has Data Monitoring Committee

Not Provided

Responsible Party

Kenneth D Candido, Chicago Anesthesia Pain Specialists

Study Sponsor ^ICMJE

Chicago Anesthesia Pain Specialists

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kenneth D Candido, M.D.

Chicago Anesthesia Pain Specialists

Information Provided By

Chicago Anesthesia Pain Specialists

Verification Date

January 2013

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

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