NCT02865512

Brief Summary

It is known that postoperative pain after thoracotomy or lobectomy is very severe, therefore, intraoperative or postoperative pain management using continuous thoracic epidural catheterization is suggested good option to prevent this complication. The spread of local anesthetics is influenced by various factors including volume, location of needle insertion, speed of injection, patient position, age, weight and height. However, there are few studies about the effect of different patient position during thoracic epidural catheterization. This study was designed to evaluate the effect of different patient position affecting thoracic epidurography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

August 4, 2016

Last Update Submit

November 28, 2017

Conditions

Thoracic Epidural Injection

Keywords

thoracic epidural injectionpatient position

Outcome Measures

Primary Outcomes (1)

  • Number of segment convered by contrast dye assessed through fluoroscopic image

    1 minutes after the completion of the intervention

Study Arms (2)

supine position

ACTIVE COMPARATOR

thoracic epidural catheterization with supine position

Procedure: thoracic epidural catheterization

flexed lateral position

ACTIVE COMPARATOR

thoracic epidural catheterization with flexed lateral position

Procedure: thoracic epidural catheterization

Interventions

thoracic epidural catheterizationPROCEDURE

thoracic epidural catheterization for the management of postoperative pain

flexed lateral positionsupine 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

Related Publications (1)

  • Hong JH, Jung SW, Park JH. Posture Influences the Extent of Spread of Contrast Medium During Thoracic Epidurography: A Prospective Randomized Trial. Pain Physician. 2017 Sep;20(6):501-508.

    PMID: 28934781DERIVED

Study Officials

  • Ji Hee Hong, MD, PhD

    Keimyung University Dongsan Medical Center

    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
Associate professor

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 12, 2016

Study Start

July 1, 2016

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)