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Ultrasound-assisted Thoracic Epidural Catheter Insertion

Primary Purpose

Abdominal Neoplasm, Thoracic Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrasound-guided TECI
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Neoplasm focused on measuring Ultrasound, Thoracic epidural catheter insertion, Fluoroscopy

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasound-guided TECI

Arm Description

After assessment of the epidural space using the loss of resistance technique with saline under ultrasound guidance, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not.

Outcomes

Primary Outcome Measures

Success rate of ultrasound-guided thoracic epidural catheter insertion
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 Outcome Measures

Number of skin punctures
complete needle withdrawal from the skin and reinsertion at a new location
Number of needle passes
First needle pass + additional needle passes (the needle returned to a plane perpendicular to the skin before reinsertion. Needle tip maneuvers toward the midline and cephalad were considered standard needle walking technique and were counted as a single pass)
First attempt success rate
only first needle pass and first skin puncture

Full Information

First Posted
March 25, 2019
Last Updated
January 14, 2020
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03890640
Brief Title
Ultrasound-assisted Thoracic Epidural Catheter Insertion
Official Title
Evaluation of the Accuracy of Real-time Ultrasound-assisted Thoracic Epidural Catheter Insertion: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 4, 2019 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Neoplasm, Thoracic Neoplasm
Keywords
Ultrasound, Thoracic epidural catheter insertion, Fluoroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided TECI
Arm Type
Experimental
Arm Description
After assessment of the epidural space using the loss of resistance technique with saline under ultrasound guidance, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided TECI
Intervention Description
When performing an ultrasound-guided thoracic epidural catheter insertion (TECI), an 18-gauge Tuohy needle will be used for interlaminar epidural access. All procedures will be performed with a paramedian approach under ultrasound-guidance and using the loss of resistance technique with saline. If the needle is deemed to be in the epidural space when the loss of resistance occurred, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not.
Primary Outcome Measure Information:
Title
Success rate of ultrasound-guided thoracic epidural catheter insertion
Description
Confirmation success of ultrasound-guided thoracic epidural catheter insertion using fluoroscopic images; success means that the catheter tip is located in the epidural space.
Time Frame
on the day of the procedure
Secondary Outcome Measure Information:
Title
Number of skin punctures
Description
complete needle withdrawal from the skin and reinsertion at a new location
Time Frame
on the day of the procedure
Title
Number of needle passes
Description
First needle pass + additional needle passes (the needle returned to a plane perpendicular to the skin before reinsertion. Needle tip maneuvers toward the midline and cephalad were considered standard needle walking technique and were counted as a single pass)
Time Frame
on the day of the procedure
Title
First attempt success rate
Description
only first needle pass and first skin puncture
Time Frame
on the day of the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Hyuk Lee, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33893174
Citation
Kim DH, Lee JH, Sim JH, Jeong W, Lee D, Kwon HM, Choi SS, Jeong SM. Real-time ultrasound-guided low thoracic epidural catheter placement: technical consideration and fluoroscopic evaluation. Reg Anesth Pain Med. 2021 Jun;46(6):512-517. doi: 10.1136/rapm-2021-102578. Epub 2021 Apr 23.
Results Reference
derived

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Ultrasound-assisted Thoracic Epidural Catheter Insertion

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