Menu
Not yet recruiting NCT06770816

Effect of Left Erector Spinae Plane Block on Left Ventricular Functions

Observational Erector Spina Plan Block Echocardiography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echocardiography.
Who it may be relevant to
Registry conditions: Erector Spina Plan Block, Echocardiography. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Detailed description

After extubation, respiratory therapy and pain management are important issues in postoperative care. Adequate postoperative pain control is necessary for a good respiratory effort. For years, the use of intravenous opioids has become the standard in pain management. Opioids administered to adequately control pain may cause sedation and respiratory depression. Due to the large number of opioid-related side effects, alternative pain relief methods are being sought.

Erector spinae area (ESP) block has recently been described in the treatment of pain after thoracic surgery (1,2,3).

The focus of this section is left thoracic ESP block, in which the cardiac sympathetic nerves (T1-T5) are involved in neural blockade. 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 have cardiac effects. Therefore, we aimed to investigate the effect of left thoracic ESP block on left ventricular functions with transthoracic echocardiography (TTE).

The study was designed as an observational study. After obtaining written informed consent from the patients, it was planned to apply the routine ultrasonography-guided ESP block to the patients. This application is performed in thoracic surgeries performed with general anesthesia as standard in our hospital.

Demographic data to be obtained, in addition to the outcomes of the above-mentioned study, will include recording height (cm), weight (kg), age (years), gender, (ASA) physical condition, and specific procedure type. Patients will be asked about tobacco and alcohol use, drug use. They will also be asked about their medical history, including lung disease, kidney disease, diabetes mellitus, neurological disease, chronic pain conditions, previous surgery or stent placement, and medications. Current preoperative laboratory tests and medication list will be recorded. Parameters measured by TTE before and 15 minutes after the block will be recorded.

Interventions

  • Other Echocardiography
    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).

Primary outcome measures

  • Echocardiographic assessment of left ventricular function [Time frame: Left ventricular function will be assessed by echocardiography 15 minutes before and 15 minutes after left high thoracic esp block.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 20031952

Identifiers

NCT: NCT06770816 · 221

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗