Thoracic Epidural InjectionNCT03128788
Comparison of Thoracic Epidural Pressure in the Prone and Lateral Decubitus Position
A study testing thoracic epidural catheterization in people with Thoracic Epidural Injection, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thoracic Epidural Injection
- What is being tested?
- thoracic epidural catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2017to 2 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lung cancer
- liver cancer
- stomach cancer
- pancreas cancer
Who cannot join
- coagulopathy
- infection
- previous spine fusion at thoracic level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Thoracic Epidural Injection
- Being tested
- thoracic epidural catheterization
- Keywords
- epidurography epidural pressure patient posture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic epidural catheterizationProcedure or surgery
thoracic epidural catheterization thoracic epidural catheterization for the management of postoperative pain
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: supine position | Active comparator | Active Comparator: supine position thoracic epidural catheterization with supine position Receives: Procedure: thoracic epidural catheterization |
| Active Comparator: flexed lateral position | Active comparator | Active Comparator: flexed lateral position thoracic epidural catheterization with flexed lateral position Receives: Procedure: thoracic epidural catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidural pressure
Epidural pressure (mmHg) measurement using pressure transducer between different posture
Measured: 15 minutes after the completion of the intervention
Secondary outcomes (1)
Contrast dye assessment
Number of segment convered by contrast dye assessed through fluoroscopic image
Measured: 5 minutes after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start2 Mar 2017
- Primary completion2 Jan 2018
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Epidural InjectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hee Hong, Keimyung University Dongsan Medical Center
- Investigators
- Ji Hee Hong, PhD, Principal investigator, Keimyung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128788
- Sponsor's protocol ID
- 2016-12-048
- Status last verified
- Mar 2018
- First submitted
- 20 Apr 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Extent of Epidurography and Thoracic Epidural Pressure in the Prone and Lateral Decubitus Position
- ClinicalTrials.gov ID
- NCT03128788
- Acronym / sponsor ID
- 2016-12-048
- Conditions
- Thoracic Epidural Injection
- Keywords
- epidurography epidural pressure patient posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: supine position | Active comparator | Procedure: thoracic epidural catheterizationActive Comparator: supine position thoracic epidural catheterization with supine position |
| Active Comparator: flexed lateral position | Active comparator | Procedure: thoracic epidural catheterizationActive Comparator: flexed lateral position thoracic epidural catheterization with flexed lateral position |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- lung cancer
- liver cancer
- stomach cancer
- pancreas cancer
Key exclusion criteria (3 listed)
- coagulopathy
- infection
- previous spine fusion at thoracic level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracic epidural catheterizationthoracic epidural catheterization thoracic epidural catheterization for the management of postoperative pain | Procedure or surgery | Active Comparator: flexed lateral position, Active Comparator: supine position |
Primary outcome
Epidural pressure
Time frame: 15 minutes after the completion of the intervention
Epidural pressure (mmHg) measurement using pressure transducer between different posture
1 secondary outcome
Contrast dye assessment
Time frame: 5 minutes after the completion of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Hee Hong, PhD principal investigator
Keimyung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic epidural catheterization in people with Thoracic Epidural Injection, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidural pressure (time frame: 15 minutes after the completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.