Erector Spina Plan BlockESP-LV ECHONCT06770816
Effect of Left Erector Spinae Plane Block on Left Ventricular Functions
An observational study of Erector Spina Plan Block and Echocardiography, run by Aydin Adnan Menderes University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Erector Spina Plan Block, Echocardiography
- What is being tested?
- Echocardiography
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2025to 2 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who will undergo elective left-sided thoracic surgery, ASA I-III and between the ages of 18-75
Who may be able to join
- Patients undergoing elective left-sided thoracic surgery ASA I-III 18-75 years of age
Who cannot join
- 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
Show all 9Show fewer
- Use of chronic opioids
- Psychiatric disorders
- Presence of infection at the injection site
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read the 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.
- Conditions
- Erector Spina Plan Block, Echocardiography
- Being tested
- Echocardiography
- Keywords
- erector spina plan block, left ventricle, echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Left ventricular function will be assessed by echocardiography 15 minutes before and 15 minutes after left high thoracic esp block.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start10 Jan 2025 (estimated)
- Primary completion2 Jan 2026 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erector Spina Plan BlockStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ferdi gülaştı, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770816
- Sponsor's protocol ID
- 221
- Acronym
- ESP-LV ECHO
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 20031952
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Left Erector Spinae Plane Block on Left Ventricular Functions
- ClinicalTrials.gov ID
- NCT06770816
- Acronym / sponsor ID
- ESP-LV ECHO / 221
- Conditions
- Erector Spina Plan Block, Echocardiography
- Keywords
- erector spina plan block, left ventricle, echocardiography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (estimated)
- Primary completion
- 2 Jan 2026 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| erector spina plan block | – | Other: EchocardiographyESP 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo elective left-sided thoracic surgery, ASA I-III and between the ages of 18-75
Key inclusion criteria (1 listed)
- Patients undergoing elective left-sided thoracic surgery ASA I-III 18-75 years of age
Key exclusion criteria (9 listed)
- Refusal at enrollment
- Request for withdrawal from the study
- Inability to give informed consent
- Emergency surgery
- Bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyHR, 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 | Other | erector spina plan block |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Background: PubMed 20031952Missant 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Erector Spina Plan Block and Echocardiography, run by Aydin Adnan Menderes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ferdi gülaştı (+905054929650, ferdigulasti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06770816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.