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Clinical Trials/NCT01764932
NCT01764932
Unknown
Not Applicable

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

Chicago Anesthesia Pain Specialists1 site in 1 country60 target enrollmentDecember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients Undergoing Thoracic Surgery
Sponsor
Chicago Anesthesia Pain Specialists
Enrollment
60
Locations
1
Primary Endpoint
Presumed intervertebral level of epidural catheter
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
December 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kenneth D Candido

Chairman of the Anesthesia Department, Advocate Illinois Masonic Medical Center

Chicago Anesthesia Pain Specialists

Eligibility 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

Outcomes

Primary Outcomes

Presumed intervertebral level of epidural catheter

Time Frame: During procedure

At the time of thoracic epidural catheter insertion

Secondary Outcomes

  • Radiologic confirmation of epidural catheter placement(Post procedure within one week.)
  • Change in Numeric Rating Pain Score from baseline(1, 24 and 48 hrs)

Study Sites (1)

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