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.

Study Overview

• Status: Unknown
• Conditions: Patients Undergoing Thoracic Surgery; Patients Undergoing Upper Abdominal Surgery
• Intervention / Treatment: Procedure: Fluoroscopic imaging

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Advocate Illinois Masonic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presumed intervertebral level of epidural catheter	At the time of thoracic epidural catheter insertion	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiologic confirmation of epidural catheter placement	Radiology department will assess within one week after the procedure the images, to confirm the epidural catheter placement.	Post procedure within one week.
Change in Numeric Rating Pain Score from baseline	1, 24, and 48 hrs after the end of the surgery.	1, 24 and 48 hrs

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction 48 hrs after the end of surgery	Post procedure at 48 hours

Collaborators and Investigators

• Sponsor: Chicago Anesthesia Pain Specialists
• Investigators: Principal Investigator: Kenneth D Candido, M.D., Chicago Anesthesia Pain Specialists

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: January 2, 2013
• First Submitted That Met QC Criteria: January 8, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: Advocate-IRB-5242