NCT03789955

Brief Summary

The aim of the present study is to compare contralateral oblique view with the lateral view for fluoroscopic guided mid-thoracic epidural assess.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

December 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 22, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

December 27, 2018

Last Update Submit

November 18, 2019

Conditions

Herpes ZosterPostherpetic NeuralgiaCancer

Keywords

FluoroscopyContralateral Oblique ViewThoracic epidural blockMid thoracic epidural space

Outcome Measures

Primary Outcomes (1)

  • Distance between the tip of epidural needle and the baseline (CLO view - ventral interlaminar line, lateral view - spinolaminar line) at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)

    Location of the needle tip was defined as being significantly before the baseline (-2), just before the baseline (-1), on the baseline (0), just after the baseline (+1), or significantly after the baseline (+2).

    One day after the procedure

Secondary Outcomes (1)

  • The quality of needle tip visualization at each view (CLO view at 40 degrees, 50 degrees, 60 degrees, CLO measured view, and lateral view)

    One day after the procedure

Study Arms (1)

Fluoroscopic-guided TEB

EXPERIMENTAL

After assessment of the epidural space using the loss of resistance technique with air under fluoroscopic guidance, six fluoroscopic views will be obtained: true anteroposterior, contralateral oblique (CLO) at 40 degrees, 50 degrees, 60 degrees, CLO measured, and lateral for comparison CLO view with lateral view.

Procedure: Fluoroscopic-guided TEB

Interventions

Fluoroscopic-guided TEBPROCEDURE

When performing a fluoroscopic-guided thoracic epidural block (TEB), an 18-gauge Tuohy needle will be used for interlaminar epidural access. If the epidural space was accessed under fluoroscopic guidance and using the loss of resistance technique with air. All procedures will be performed with a paramedian approach under the true AP and lateral view at first, If the interlaminar space is not visible, the CLO view will be used. If the needle is deemed to be in the epidural space when the loss occurred, six fluoroscopic views will be obtained: true AP, CLO at 40 degrees, 50 degrees, 60 degrees, CLO measured, and lateral. The CLO measured angle will be determined by measuring the angle between the superior lamina and spinous process on the midsagittal plane on thoracic MRI or CT.

Fluoroscopic-guided TEB

Eligibility Criteria

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

You may qualify if:

  • Scheduled for mid thoracic (T4-T8) epidural block or catheter insertion
  • ≤ age \<80
  • Presence of thoracic MRI or CT
  • 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 (2)

Asan medical center

Seoul, 05505, South Korea

Location

Seong-Soo Choi

Seoul, 05505, South Korea

Location

Related Publications (1)

  • Kim DH, Yoon SH, Lee J, Park H, Sim JH, Choi SS. Evaluation of Contralateral Oblique and Lateral Views for Mid-Thoracic Epidural Access: A Prospective Observational Study. Pain Physician. 2021 Jan;24(1):E51-E59.

    PMID: 33400438DERIVED

MeSH Terms

Conditions

Herpes ZosterNeuralgia, PostherpeticNeoplasms

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seong-Soo Choi, MD, PhD

    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
Assistant Professor

Study Record Dates

First Submitted

December 27, 2018

First Posted

December 31, 2018

Study Start

February 22, 2019

Primary Completion

November 7, 2019

Study Completion

November 7, 2019

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations

KR(2)