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Clinical Trials/NCT03890640
NCT03890640
Completed
Not Applicable

Evaluation of the Accuracy of Real-time Ultrasound-assisted Thoracic Epidural Catheter Insertion: a Pilot Study

Asan Medical Center1 site in 1 country38 target enrollmentJuly 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Neoplasm
Sponsor
Asan Medical Center
Enrollment
38
Locations
1
Primary Endpoint
Success rate of ultrasound-guided thoracic epidural catheter insertion
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The aim of the present study is to access the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy.

Detailed Description

Thoracic epidural anesthesia has been associated with reduced acute postoperative pain for a wide variety of surgical procedures. It has also been associated with reductions in perioperative cardiac stress, chronic post-thoracotomy pain, and improvements in postoperative pulmonary function. Although a variety of methods can be used to confirm the position of the epidural needle in the epidural space, a blind technique and fluoroscopic guided approach are a widely used method. A thoracic epidural block is a relatively more difficult procedure than procedures used in other regions, because the spinous process of the thoracic vertebra is longer than that of the lumbar vertebra, and the area through which the needle can approach the epidural space is relatively smaller due to an acute angle and larger distance between the skin and the epidural space. Therefore, the success rate of thoracic epidural intervention is only about 68% under a blind technique due to inadequate position of the needle tip, misplacement, occlusion, and migration of the catheter. Although fluoroscopic guided thoracic epidural intervention is the safest and most accurate method to identify the correct anatomical structures and confirm the epidural space with contrast medium, its use is limited because of the difficulty of using fluoroscope and the burden of radiation exposure. As the use of ultrasound has become popularized and universal, it has been widely used in regional anesthesia and analgesia, has continuously replaced the modality such as a blind technique and fluoroscopic guidance. Ultrasound-guided thoracic epidural catheter insertion was also recently investigated, and then it was conducted successfully in 15 cases of thoracic and upper abdominal surgery. Moreover, it showed several advantages including lowering the number of needle passes and increasing the success rate. However, it has not yet been studied how accurately the catheter is located in the thoracic epidural space during thoracic epidural catheter insertion using real-time ultrasound. Although it is possible to speculate the success of the thoracic epidural catheterization clinically, the identification of the location of the catheter is only possible under fluoroscopic guidance. Therefore, in the present study, we aimed to confirm the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy with contrast medium.

Registry
clinicaltrials.gov
Start Date
July 4, 2019
End Date
December 20, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jong Hyuk Lee

Clinical professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients who will undergo upper abdomen or thoracic surgery
  • Scheduled for thoracic epidural catheter insertion
  • 20 ≤ age \<80
  • When obtaining informed consent voluntarily

Exclusion Criteria

  • Allergy to local anesthetics and contrast dye, and steroid
  • Use of anticoagulants or antiplatelet medication, coagulopathy
  • Infection at the insertion site
  • Neurological or psychiatric disorders
  • Prior spine instrumentation
  • Pregnancy

Outcomes

Primary Outcomes

Success rate of ultrasound-guided thoracic epidural catheter insertion

Time Frame: on the day of the procedure

Confirmation success of ultrasound-guided thoracic epidural catheter insertion using fluoroscopic images; success means that the catheter tip is located in the epidural space.

Secondary Outcomes

  • First attempt success rate(on the day of the procedure)
  • Number of skin punctures(on the day of the procedure)
  • Number of needle passes(on the day of the procedure)

Study Sites (1)

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