Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Patients Undergoing Thoracic Surgery, Patients Undergoing Upper Abdominal Surgery

Intervention / Treatment
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* Procedure: Fluoroscopic imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Thoracic epidural catheter insertion<br>Fluoroscopic imaging. For patients undergoing thoracic epidural analgesia (TEA) with catheter placement for pain associated with thoracic or upper abdominal surgery | Procedure: Fluoroscopic imaging<br>* 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.<br>|

What is the study measuring?
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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 |