Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging

Not Applicable

• Conditions: Patients Undergoing Thoracic Surgery; Patients Undergoing Upper Abdominal Surgery
• Interventions: Procedure: Fluoroscopic imaging

• Registration Number: NCT01764932
• Lead Sponsor: Chicago Anesthesia Pain Specialists

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thoracic epidural catheter insertion	Fluoroscopic imaging	Fluoroscopic imaging. For patients undergoing thoracic epidural analgesia (TEA) with catheter placement for pain associated with thoracic or upper abdominal surgery

Primary Outcome Measures

Name	Time	Method
Presumed intervertebral level of epidural catheter	During procedure	At the time of thoracic epidural catheter insertion

Secondary Outcome Measures

Name	Time	Method
Radiologic confirmation of epidural catheter placement	Post 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 baseline	1, 24 and 48 hrs	1, 24, and 48 hrs after the end of the surgery.

Trial Locations

Locations (1)

Advocate Illinois Masonic Medical Center; 🇺🇸 Chicago, Illinois, United States