Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging
Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 2, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedSeptember 14, 2017
September 1, 2017
6.9 years
January 2, 2013
September 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Presumed intervertebral level of epidural catheter
At the time of thoracic epidural catheter insertion
During procedure
Secondary Outcomes (2)
Radiologic confirmation of epidural catheter placement
Post procedure within one week.
Change in Numeric Rating Pain Score from baseline
1, 24 and 48 hrs
Other Outcomes (1)
Patient satisfaction
Post procedure at 48 hours
Study Arms (1)
Thoracic epidural catheter insertion
OTHERFluoroscopic imaging. For patients undergoing thoracic epidural analgesia (TEA) with catheter placement for pain associated with thoracic or upper abdominal surgery
Interventions
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.
Eligibility Criteria
You may qualify if:
- years old patients
- Patients undergoing thoracic surgery
- Patients undergoing upper abdominal surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth D Candido, M.D.
Chicago Anesthesia Pain Specialists
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman of the Anesthesia Department, Advocate Illinois Masonic Medical Center
Study Record Dates
First Submitted
January 2, 2013
First Posted
January 10, 2013
Study Start
December 1, 2011
Primary Completion
November 1, 2018
Study Completion
December 1, 2018
Last Updated
September 14, 2017
Record last verified: 2017-09