NCT03890640

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 4, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

March 25, 2019

Last Update Submit

January 14, 2020

Conditions

Abdominal NeoplasmThoracic Neoplasm

Keywords

UltrasoundThoracic epidural catheter insertionFluoroscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

    on the day of the procedure

Secondary Outcomes (3)

  • Number of skin punctures

    on the day of the procedure

  • Number of needle passes

    on the day of the procedure

  • First attempt success rate

    on the day of the procedure

Study Arms (1)

Ultrasound-guided TECI

EXPERIMENTAL

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.

Procedure: Ultrasound-guided TECI

Interventions

Ultrasound-guided TECIPROCEDURE

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.

Ultrasound-guided TECI

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan medical center

Seoul, 05505, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33893174DERIVED

MeSH Terms

Conditions

Abdominal NeoplasmsThoracic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Jong-Hyuk Lee, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 26, 2019

Study Start

July 4, 2019

Primary Completion

December 12, 2019

Study Completion

December 20, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

KR(1)