NCT06770790

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2026

Completed
Last Updated

January 13, 2025

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

December 27, 2024

Last Update Submit

January 7, 2025

Conditions

Keywords

thoracic epidural anesthesialeft ventriclestrain echocardiographycardiac function

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.

Other: strain echocardiography

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

thoracal epidural anesthesia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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