Chicago, Illinois 60657

  • Patients Undergoing Upper Abdominal Surgery

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.


Study summary:

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.


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


Study is Available At:


Original ID:

Advocate-IRB-5242


NCT ID:

NCT01764932


Secondary ID:


Study Acronym:


Brief Title:

Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Chicago Anesthesia Pain Specialists


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kenneth D Candido, M.D.
Principal Investigator
Chicago Anesthesia Pain Specialists

Study Dates

Start Date:December 2011
Completion Date:December 2018
Completion Type:Anticipated
Primary Completion Date:November 2018
Primary Completion Type:Anticipated
Verification Date:September 2017
Last Changed Date:September 13, 2017
First Received Date:January 2, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in Numeric Rating Pain Score from baseline
Time Frame:1, 24 and 48 hrs
Safety Issues:False
Description:1, 24, and 48 hrs after the end of the surgery.
Outcome Type:Secondary Outcome
Measure:Radiologic confirmation of epidural catheter placement
Time Frame:Post procedure within one week.
Safety Issues:False
Description:Radiology department will assess within one week after the procedure the images, to confirm the epidural catheter placement.
Outcome Type:Primary Outcome
Measure:Presumed intervertebral level of epidural catheter
Time Frame:During procedure
Safety Issues:False
Description:At the time of thoracic epidural catheter insertion

Study Interventions

Intervention Type:Procedure
Name:Fluoroscopic imaging
Description: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.
Arm Name:Thoracic epidural catheter insertion

Study Arms

Study Arm Type:Other
Arm Name:Thoracic epidural catheter insertion
Description:Fluoroscopic imaging. For patients undergoing thoracic epidural analgesia (TEA) with catheter placement for pain associated with thoracic or upper abdominal surgery

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Chicago Anesthesia Pain Specialists

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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