Effect of Thoracic Epidural Anesthesia on Left Ventricular Functions: a Strain Echocardiography Study

Not yet recruiting

• Conditions: Thoracal Epidural Block; Echocardiography

• Registration Number: NCT06770790
• Lead Sponsor: Aydin Adnan Menderes University

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.

Detailed Description

The study was designed as an observational study. Our study will be conducted for 12 months after receiving ethical committee approval. 23 patients are planned to be included in the study. TTE will be performed when the patients arrive at the preoperative room for the operation. Then, thoracic epidural anesthesia will be performed. After the block, all usual medications, except ACE inhibitors, will be continued according to hospital protocol for 15 days of surgery. Patients will be given up to 2 mg midazolam and 7 ml/kg 0.5% isotonic 15 minutes before the epidural catheter is administered. A TTE will be performed before the epidural catheter is placed. After appropriate local anesthesia, the epidural catheter will be placed while the patient is in a sitting position. The puncture will be performed between t6-t7 and t8-t9 using the midline approach with the "loss of resistance" technique. The catheter will be inserted 3-4 cm into the epidural space and an epidural lidocaine bolus (10 ml at 2% concentration) will be administered while the patients are in the supine position. TTE will be performed again after 15 minutes. At these stages, hemodynamic values will also be recorded. 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study Start: 2025-01-10
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2026-01-05
• Study Completion: 2026-02-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Elective payment options ASA I-III Ages 18-75

Exclusion Criteria

1. Refusal at enrollment
2. Request for withdrawal from the study
3. Inability to give informed consent
4. Emergency surgery
5. Bleeding diathesis
6. Presence of contraindications to the LA agents used in this study
7. Use of chronic opioids
8. Psychiatric disorders
9. Presence of infection at the injection site

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Echocardiographic assessment of left ventricular function	Left ventricular function will be assessed by echocardiography 15 minutes before and 15 minutes after high TEA.	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.