Systemic Immune-inflammatory IndexNCT07137702
Impact of Erector Spinae Plane Block on Systemic Immune-inflammation Index
An observational study of Systemic Immune-inflammatory Index and Erector Spinae Plane Block, run by Taner Abdullah at 1 site in Turkey (Türkiye).
Trial summary
The primary objective of the study is to determine whether there is a relationship between postoperative SII and erector spinae plane block application. If data emerges indicating a more suppressed inflammatory response in patients undergoing block, widespread use of this block in the specified patient group would… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Systemic Immune-inflammatory Index, Erector Spinae Plane Block, Breast Conserving Surgery
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 15 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women who have undergone breast-conserving surgery for malignant causes
Inclusion Criteria: ASA score ≤ 3, breast-conversing surgery, age > 18 -
Exclusion Criteria: ASA score > 3, reoperation, surgical wound infection, chemotherapy in less than 2 weeks, bening lesions
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam ve Sakura City Hospital
Istanbul
About this study
Official title: Impact of Erector Spinae Plane Block on Systemic Immune-inflammation Index in Breast-conserving Surgery: A Retrospective Cohort Study
The primary objective of the study is to determine whether there is a relationship between postoperative SII and erector spinae plane block application. If data emerges indicating a more suppressed inflammatory response in patients undergoing block, widespread use of this block in the specified patient group would reflect the clinical significance of the study.
The searches did not uncover any studies investigating the effects of trunk blocks, such as erector spinae plane block, on postoperative systemic inflammatory response, indicating that this study could make a significant contribution to the literature.
Read the detailed description
Because the study will be conducted retrospectively, it carries no potential risks.
If it can be demonstrated that blocking has a suppressive effect on the inflammatory response, the main expected benefit of the study is its widespread use to improve postoperative outcomes.
- Being tested
- Erector Spinae Plane Block
- Keywords
- systemic immune-inflammatory index, erector spinae plane block, breast conserving surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
A standardized perioperative care management protocol is applied for all breast-conserving surgery procedures in our department. All patients are informed about ESPB and offered its application preoperatively. Patients who accept the procedure receive ESPB (preoperatively, in the sitting position, at the level of ipsilateral T4 vertebra, USG guided, out-of-plane approach) while those who refuse are subjected to routine intravenous analgesia protocols. All blocks were performed by an anesthesiologist experienced in the application of truncal blocks and 20 cc 0.5% bupivacaine (within the safe dose range for all patients to be used according to their weight) are injected and its spread is visualized under USG.
| Study group | Role | What they receive |
|---|---|---|
| ESPB + group | the patients who received erector spinae plane block Receives: Procedure: Erector Spinae Plane Block | |
| ESPB - group | the patients who didn't receive erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
systemic immune-inflammation index
Platelet count × Neutrophil count / Lymphocyte count
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start15 Jul 2025
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Immune-inflammatory IndexStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taner Abdullah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Taner Abdullah, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137702
- Sponsor's protocol ID
- 2025-225
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Erector Spinae Plane Block on Systemic Immune-inflammation Index in Breast-conserving Surgery: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07137702
- Acronym / sponsor ID
- 2025-225
- Keywords
- systemic immune-inflammatory index, erector spinae plane block, breast conserving surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Taner AbdullahUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 22 Aug 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.
The primary objective of the study is to determine whether there is a relationship between postoperative SII and erector spinae plane block application. If data emerges indicating a more suppressed inflammatory response in patients undergoing block, widespread use of this block in the specified patient group would reflect the clinical significance of the study.
The searches did not uncover any studies investigating the effects of trunk blocks, such as erector spinae plane block, on postoperative systemic inflammatory response, indicating that this study could make a significant contribution to the literature.
Detailed description
Because the study will be conducted retrospectively, it carries no potential risks.
If it can be demonstrated that blocking has a suppressive effect on the inflammatory response, the main expected benefit of the study is its widespread use to improve postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB + group | – | Procedure: Erector Spinae Plane Blockthe patients who received erector spinae plane block |
| ESPB - group | – | –the patients who didn't receive erector spinae plane block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women who have undergone breast-conserving surgery for malignant causes
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 |
|---|---|---|
| Erector Spinae Plane BlockA standardized perioperative care management protocol is applied for all breast-conserving surgery procedures in our department. All patients are informed about ESPB and offered its application preoperatively. Patients who accept the procedure receive ESPB (preoperatively, in the sitting position, at the level of ipsilateral T4 vertebra, USG guided, out-of-plane approach) while those who refuse are subjected to routine intravenous analgesia protocols. All blocks were performed by an anesthesiologist experienced in the application of truncal blocks and 20 cc 0.5% bupivacaine (within the safe dose range for all patients to be used according to their weight) are injected and its spread is visualized under USG. | Procedure or surgery | ESPB + group |
Primary outcome
systemic immune-inflammation index
Time frame: 7 days after surgery
Platelet count × Neutrophil count / Lymphocyte count
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Immune-inflammatory Index and Erector Spinae Plane Block, run by Taner Abdullah at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systemic immune-inflammation index (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025.