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Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01764932
Enrollment
60
Registered
2013-01-10
Start date
2011-12-31
Completion date
2018-12-31
Last updated
2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Thoracic Surgery, Patients Undergoing Upper Abdominal Surgery

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.

Interventions

PROCEDUREFluoroscopic 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.

Sponsors

Chicago Anesthesia Pain Specialists
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presumed intervertebral level of epidural catheterDuring procedureAt the time of thoracic epidural catheter insertion

Secondary

MeasureTime frameDescription
Radiologic confirmation of epidural catheter placementPost procedure within one week.Radiology department will assess within one week after the procedure the images, to confirm the epidural catheter placement.
Change in Numeric Rating Pain Score from baseline1, 24 and 48 hrs1, 24, and 48 hrs after the end of the surgery.

Other

MeasureTime frameDescription
Patient satisfactionPost procedure at 48 hoursPatient satisfaction 48 hrs after the end of surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026