NCT03128788

Brief Summary

It is reported that the distribution of contrast medium had an obvious correlation with the extent of sensory analgesia after injection of LA. Our previous study showed that different posture (prone vs. lateral decubitus) resulted in different degree of contrast medium spread. We supposed that differences of epidural pressure between diverse postures might be one factor contributing those differences of epidurography. This study was designed to compare the epidural pressure and extent of spread of epidurography between prone and lateral decubitus position

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 Mar 2017

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

Study Start

First participant enrolled

March 2, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

April 20, 2017

Last Update Submit

March 5, 2018

Conditions

Thoracic Epidural Injection

Keywords

epidurography epidural pressure patient posture

Outcome Measures

Primary Outcomes (1)

  • Epidural pressure

    Epidural pressure (mmHg) measurement using pressure transducer between different posture

    15 minutes after the completion of the intervention

Secondary Outcomes (1)

  • Contrast dye assessment

    5 minutes after the completion of the intervention

Study Arms (2)

Active Comparator: supine position

ACTIVE COMPARATOR

Active Comparator: supine position thoracic epidural catheterization with supine position

Procedure: thoracic epidural catheterization

Active Comparator: flexed lateral position

ACTIVE COMPARATOR

Active Comparator: flexed lateral position thoracic epidural catheterization with flexed lateral position

Procedure: thoracic epidural catheterization

Interventions

thoracic epidural catheterizationPROCEDURE

thoracic epidural catheterization thoracic epidural catheterization for the management of postoperative pain

Active Comparator: flexed lateral positionActive Comparator: supine position

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lung cancer
  • liver cancer
  • stomach cancer
  • pancreas cancer

You may not qualify if:

  • coagulopathy
  • infection
  • previous spine fusion at thoracic level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji Hee Hong

Daegu, 700712, South Korea

Location

Study Officials

  • Ji Hee Hong, PhD

    Keimyung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 25, 2017

Study Start

March 2, 2017

Primary Completion

January 2, 2018

Study Completion

February 2, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)