Clinical trial NCT06770790: Effect of Thoracic Epidural Anesthesia on Left Ventricular Functions: a Strain Echocardiography Study
Official title: Effect of Thoracic Epidural Anesthesia on Left Ventricular Functions: a Strain Echocardiography Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thoracal Epidural Block
Echocardiography
Keywords: thoracic epidural anesthesia
left ventricle
strain echocardiography
cardiac function
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Echocardiographic assessment of left ventricular function
timeFrame: Left ventricular function will be assessed by echocardiography 15 minutes before and 15 minutes after high TEA.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.