Effect of Thoracic Epidural Anesthesia on Left Ventricular Functions: a Strain Echocardiography Study
TEA-strain
1 other identifier
observational
23
0 countries
N/A
Brief Summary
Post-thoracic surgery pain management thoracic epidural catheter is the most commonly used method. Thoracic epidural anesthesia, in which cardiac sympathetic nerves (T1-T5) are involved in neural blockade, is the focus of our research. Many studies have shown a decrease in inotropic status (intrinsic function) after blockade of cardiac sympathetic innervation with thoracic epidural anesthesia (TEA).We want to examine the cardiac effects of TEA with strain echocardiography, which is an advanced echocardiography method. Therefore, we aimed to investigate the effect of TEA on left ventricular functions with strain echocardiography.
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for all trials
Started Jan 2025
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2024
CompletedStudy Start
First participant enrolled
January 10, 2025
CompletedFirst Posted
Study publicly available on registry
January 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2026
CompletedJanuary 13, 2025
December 1, 2024
12 months
December 27, 2024
January 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Echocardiographic assessment of left ventricular function
Description: Standard measurements of left ventricular systolic function include left ventricular volumes (indexed to body surface area, BSA), left ventricular ejection fraction (LVEF) according to the modified Simpson rule, time and velocity integral in the left ventricular outflow tract (TVI-LVOT), and stroke volume (SV) (= π x LVOT radius2 x TVI-LVOT). Stroke volume index (SVI) will be calculated as SV/BSA. Mitral and aortic Doppler flow profiles, left ventricular isovolumetric relaxation time, and maximum flow velocity measurements will be recorded. LV early (E-max) and late (A-max) diastolic filling will be assessed.
Left ventricular function will be assessed by echocardiography 15 minutes before and 15 minutes after high TEA.
Study Arms (1)
thoracal epidural anesthesia
After appropriate local anesthesia, the patient will be placed in the epidural area while in a sitting position. The puncture will be performed between t6-t7 and t8-t9 with a midline approach with a "loss of resistance" specialist. The catheter is inserted into the epidural space 3-4 cm and the epidural lidocaine bolus (10 ml at 2% capacity) while the pain is in the supine region.
Interventions
HR, MAP, SBP, and DBP will be recorded at baseline and 15 minutes after ESP block. Cardiac output (CO) will be calculated using echocardiographic data on stroke volume (SV) (measured from the LV outflow tract) and multiplied by HR. Two transthoracic 2D echocardiographic examinations will be performed immediately before and 15 minutes after TEA. The examinations include apical four-, two-, and three-chamber projections, mitral and aortic Doppler flow velocities. Standard measurements of left ventricular systolic function include left ventricular volumes (indexed to body surface area, BSA), left ventricular ejection fraction (LVEF) according to the modified Simpson rule, time and velocity integral in the left ventricular outflow tract (TVI-LVOT), and stroke volume (SV) (= π x LVOT radius2 x TVI-LVOT). Stroke volume index (SVI) will be calculated as SV/BSA. Mitral and aortic Doppler flow profiles, left ventricular isovolumetric relaxation time, maximum flow velocity will be recorded for m
Eligibility Criteria
Patients who will have a thoracic epidural catheter inserted for thoracic surgery and are between the ages of 18-75 and in the ASA1-3 group.
You may qualify if:
- Elective payment options ASA I-III Ages 18-75
You may not qualify if:
- Refusal at enrollment
- Request for withdrawal from the study
- Inability to give informed consent
- Emergency surgery
- Bleeding diathesis
- Presence of contraindications to the LA agents used in this study
- Use of chronic opioids
- Psychiatric disorders
- Presence of infection at the injection site
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Rex S, Missant C, Segers P, Wouters PF. Thoracic epidural anesthesia impairs the hemodynamic response to acute pulmonary hypertension by deteriorating right ventricular-pulmonary arterial coupling. Crit Care Med. 2007 Jan;35(1):222-9. doi: 10.1097/01.CCM.0000250357.35250.A2.
PMID: 17095942BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- asst.prof.dr
Study Record Dates
First Submitted
December 27, 2024
First Posted
January 13, 2025
Study Start
January 10, 2025
Primary Completion
January 5, 2026
Study Completion
February 5, 2026
Last Updated
January 13, 2025
Record last verified: 2024-12