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Comparison of Thoracic Epidural Pressure in the Prone and Lateral Decubitus Position

Primary Purpose

Thoracic Epidural Injection

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
thoracic epidural catheterization
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Epidural Injection focused on measuring epidurography epidural pressure patient posture

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • coagulopathy
  • infection
  • previous spine fusion at thoracic level

Sites / Locations

  • Ji Hee Hong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Active Comparator: supine position

Active Comparator: flexed lateral position

Arm Description

Active Comparator: supine position thoracic epidural catheterization with supine position

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Contrast dye assessment
Number of segment convered by contrast dye assessed through fluoroscopic image

Full Information

First Posted
April 20, 2017
Last Updated
March 5, 2018
Sponsor
Keimyung University Dongsan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03128788
Brief Title
Comparison of Thoracic Epidural Pressure in the Prone and Lateral Decubitus Position
Official Title
Comparison of Extent of Epidurography and Thoracic Epidural Pressure in the Prone and Lateral Decubitus Position
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
February 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center

4. Oversight

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

5. Study Description

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
Detailed Description
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 potential 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 affeting the epidural pressure and the extent of spread of contrast medium during thoracic epidural catheterization. Studies of lumbar epidural blockade have shown that lateral position can produce 0-3 segment more to the dependent position compared to the supine position. When the same amount of local anesthetic was injected in supine of sitting position, the most cephalad level of spread was indifferent. Recent studies showed that neck flexion demonstrated significant cephalad spread of contrast dye in high thoracic epidural blockade. The purpose of this study was to compare and evaluate the changes of epidural pressure with extent of spread of contrast medium between different posture

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Epidural Injection
Keywords
epidurography epidural pressure patient posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: supine position
Arm Type
Active Comparator
Arm Description
Active Comparator: supine position thoracic epidural catheterization with supine position
Arm Title
Active Comparator: flexed lateral position
Arm Type
Active Comparator
Arm Description
Active Comparator: flexed lateral position thoracic epidural catheterization with flexed lateral position
Intervention Type
Procedure
Intervention Name(s)
thoracic epidural catheterization
Intervention Description
thoracic epidural catheterization thoracic epidural catheterization for the management of postoperative pain
Primary Outcome Measure Information:
Title
Epidural pressure
Description
Epidural pressure (mmHg) measurement using pressure transducer between different posture
Time Frame
15 minutes after the completion of the intervention
Secondary Outcome Measure Information:
Title
Contrast dye assessment
Description
Number of segment convered by contrast dye assessed through fluoroscopic image
Time Frame
5 minutes after the completion of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: lung cancer liver cancer stomach cancer pancreas cancer Exclusion Criteria: coagulopathy infection previous spine fusion at thoracic level
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Hee Hong, PhD
Organizational Affiliation
Keimyung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ji Hee Hong
City
Daegu
ZIP/Postal Code
700712
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Thoracic Epidural Pressure in the Prone and Lateral Decubitus Position

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