NCT06770816

Brief Summary

Many studies have shown a decrease in inotropic status (intrinsic function) after blockade of cardiac sympathetic innervation with thoracic epidural anesthesia (TEA) (4,5). There is no study in the literature investigating the cardiac effects of left thoracic ESP block. We think that left thoracic ESP block, like TEA, may also have cardiac effects. Therefore, we aimed to investigate the effect of left thoracic ESP block on left ventricular functions with transthoracic echocardiography (TTE).

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

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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 2, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 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

erector spina plan blockleft ventricleechocardiography

Outcome Measures

Primary Outcomes (1)

  • Echocardiographic assessment of left ventricular function

    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 left high thoracic esp block.

Study Arms (1)

erector spina plan block

ESP block will be applied from the midline 3 cm lateral to the T5 level under ultrasound guidance. After the area is cleaned with povidone iodine before the block, the T5 transverse process will be determined using a linear ultrasound probe. Local anesthetic will be applied between the transverse process and the erector spinae muscle with the help of an insulated needle designed for peripheral block procedures. The location of the needle will be verified with the hydrodissection method with physiological serum without local anesthesia. After the location of the needle is verified, 0.25% bupivacaine 20 ml mixture will be applied.

Other: 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. Changes in LV systolic function will be assessed with three parameters: fractional shortening (FS), ejection fraction (EF) using the Simpson method and S' wave of tissue Doppler imaging (TDI) of the mitral annulus (average of values at the medial and lateral annulus). LV diastolic function will be assessed with three parameters and interpreted according to the European Association of Cardiovascular Imaging guidelines. Pulsed wave (PW) Doppler of trans-mitral flow will be used to obtain the ratio between early (e) and late (atrial, a) waves. A PW Doppler between the LV outflow tract and the mitral valve will be performed to estimate the iso-volumetric relaxation time IVRT. TDI will be used to investigate myocardial relaxation at the mitral annular level (ear

erector spina plan block

Eligibility Criteria

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

Patients who will undergo elective left-sided thoracic surgery, ASA I-III and between the ages of 18-75

You may qualify if:

  • Patients undergoing elective left-sided thoracic surgery ASA I-III 18-75 years of age

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)

  • Missant C, Claus P, Rex S, Wouters PF. Differential effects of lumbar and thoracic epidural anaesthesia on the haemodynamic response to acute right ventricular pressure overload. Br J Anaesth. 2010 Feb;104(2):143-9. doi: 10.1093/bja/aep354. Epub 2009 Dec 22.

    PMID: 20031952BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass. prof.dr

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 13, 2025

Study Start

January 10, 2025

Primary Completion

January 2, 2026

Study Completion

February 2, 2026

Last Updated

January 13, 2025

Record last verified: 2024-12