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

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

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

Study Overview

• Status: Completed
• Conditions: Thoracic Epidural Injection
• Intervention / Treatment: Procedure: thoracic epidural catheterization

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700712
    • Ji Hee Hong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• coagulopathy
• infection
• previous spine fusion at thoracic level

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: supine position; Active Comparator: supine position thoracic epidural catheterization with supine position	Procedure: thoracic epidural catheterization; thoracic epidural catheterization thoracic epidural catheterization for the management of postoperative pain
Active Comparator: Active Comparator: flexed lateral position; Active Comparator: flexed lateral position thoracic epidural catheterization with flexed lateral position	Procedure: thoracic epidural catheterization; thoracic epidural catheterization thoracic epidural catheterization for the management of postoperative pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidural pressure	Epidural pressure (mmHg) measurement using pressure transducer between different posture	15 minutes after the completion of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast dye assessment	Number of segment convered by contrast dye assessed through fluoroscopic image	5 minutes after the completion of the intervention

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2017
• Primary Completion (Actual): January 2, 2018
• Study Completion (Actual): February 2, 2018

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: epidurography epidural pressure patient posture
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Aneurysm; Aneurysm, Dissecting; Pressure Ulcer
• Other Study ID Numbers: 2016-12-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No