Erector Spinae Plane BlockNCT06954324
Investigation of the Effect of Erector Spinae Plane Block on Systemic Immuno-Inflammatory Index
A study testing Erector spinae plane block in people with Erector Spinae Plane Block and Systemic Immune-inflammatory Index, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Erector spinae plane block (ESPB) is a novel interfascial block technique first described by Forero in 2016. It has been reported to be effective in various clinical indications. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Erector Spinae Plane Block, Systemic Immune-inflammatory Index, Breast Cancer
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 1 Feb 2023
- Phase
- Interventional
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-75 years
- ASA (American Society of Anesthesiologists) physical status I-II-III
- Undergoing unilateral breast cancer surgery under general anesthesia
- Volunteered to participate in the study and signed informed consent
Who cannot join
- Allergy or contraindication to local anesthetics
- Coagulopathy or on anticoagulant therapy
- Infection at the injection site
- History of chronic pain or opioid use
- Neurological or psychiatric disorders affecting pain perception
- Refusal to receive regional anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Erector Spinae Plane Block on Systemic Immuno-Inflammatory Index in Breast Cancer Surgery: A Prospective Randomized Controlled Study
Erector spinae plane block (ESPB) is a novel interfascial block technique first described by Forero in 2016. It has been reported to be effective in various clinical indications. In ESPB, local anesthetic is injected between the deep fascia of the erector spinae muscle and the transverse process of the vertebra, allowing cephalocaudal spread along the erector spinae muscle. The goal of the injection is to provide sensory blockade by affecting the anterior rami of the spinal nerves in the region.
ESPB has been used during breast and axillary lymph node surgeries to manage postoperative pain. In addition to tumor cells, immune and inflammatory cells such as neutrophils, platelets, and lymphocytes contribute to the dissemination and invasion of tumor cells into the peripheral circulation. Noninvasive biomarkers such as serum inflammatory markers are increasingly valued for their simplicity and predictive potential. Platelets have been shown to facilitate epithelial-mesenchymal transition of tumor cells; neutrophils support tumor adhesion via growth factors such as VEGF and proteases; lymphocytes play a role in modulating the host immune response to malignancy.
Read more
The systemic immune-inflammatory index (SII), calculated as (platelet count × neutrophil count) / lymphocyte count, is a relatively new composite marker that reflects immune and inflammatory responses. It has been evaluated as a prognostic biomarker in several cancer-related studies.
Postoperative pain and surgical stress activate systemic inflammatory responses. ESPB is performed as part of postoperative analgesia in patients undergoing breast cancer surgery under general anesthesia, based on voluntary participation. The aim of this study is to evaluate the effect of ESPB on postoperative SII levels in comparison to other analgesia modalities.
- Being tested
- Erector spinae plane block
- Keywords
- Breast cancer, Systemic immune inflammatory index (SII), Erector spinae plane block (ESPB), Stress response
- Medical subject headings
- Breast Neoplasms, Fractures, Stress
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
This study aims to compare the effects of erector spinae plane block (ESPB) and systemic tramadol use as postoperative analgesia methods on the systemic immune-inflammatory index (SII) in patients undergoing breast cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block | Experimental | Preoperative thoracic level 4 ESP block was applied Receives: Procedure: Erector spinae plane block |
| Control | No intervention | Group with analgesia provided by Contromal (IM) without blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Immune-Inflammation Index (SII)
Systemic immune-inflammation index (SII) will be calculated using the formula:
SII = (Platelet count × Neutrophil count) / Lymphocyte count. This index will be used to evaluate the effect of erector spinae plane block (ESPB) on postoperative systemic inflammation in patients undergoing breast cancer surgery.
Measured: 6 hours postoperatively
Secondary outcomes (1)
Postoperative Pain Score
Postoperative pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at rest and during movement at predefined time points to evaluate the analgesic effectiveness of erector spinae plane block (ESPB).
Measured: At 0, 2, 4, and 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 Mar 2021
- Primary completion15 Mar 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Erector Spinae Plane BlockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Gültekin, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954324
- Sponsor's protocol ID
- NamikKU-AGultekin-Ezgi2025
- Status last verified
- May 2025
- First submitted
- 14 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy and confidentiality concerns, individual participant data (IPD) will not be made available to other researchers. The data will remain confidential, in accordance with institutional and regulatory guidelines.
Publications
He W, Wu Z, Zu L, Sun H, Yang X. Application of erector spinae plane block guided by ultrasound for postoperative analgesia in breast cancer surgery: A randomized controlled trial. Cancer Commun (Lond). 2020 Mar;40(2-3):122-125. doi: 10.1002/cac2.12013. Epub 2020 Mar 16. No abstract available.
PubMed 32175686Liu J, Shi Z, Bai Y, Liu L, Cheng K. Prognostic significance of systemic immune-inflammation index in triple-negative breast cancer. Cancer Manag Res. 2019 May 14;11:4471-4480. doi: 10.2147/CMAR.S197623. eCollection 2019.
PubMed 31191009Gulay E, Gultekin A, Yildirim I, Arar C, Ozkan Gurdal S. Comparison of erector spinae plane block and tramadol on postoperative systemic immune-inflammatory response in breast cancer surgery: A prospective randomized controlled trial. Medicine (Baltimore). 2025 Sep 12;104(37):e44466. doi: 10.1097/MD.0000000000044466.
PubMed 40958235
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Erector Spinae Plane Block on Systemic Immuno-Inflammatory Index in Breast Cancer Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06954324
- Acronym / sponsor ID
- NamikKU-AGultekin-Ezgi2025
- Keywords
- Breast cancer, Systemic immune inflammatory index (SII), Erector spinae plane block (ESPB), Stress response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 1 May 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.
Erector spinae plane block (ESPB) is a novel interfascial block technique first described by Forero in 2016. It has been reported to be effective in various clinical indications. In ESPB, local anesthetic is injected between the deep fascia of the erector spinae muscle and the transverse process of the vertebra, allowing cephalocaudal spread along the erector spinae muscle. The goal of the injection is to provide sensory blockade by affecting the anterior rami of the spinal nerves in the region.
ESPB has been used during breast and axillary lymph node surgeries to manage postoperative pain. In addition to tumor cells, immune and inflammatory cells such as neutrophils, platelets, and lymphocytes contribute to the dissemination and invasion of tumor cells into the peripheral circulation. Noninvasive biomarkers such as serum inflammatory markers are increasingly valued for their simplicity and predictive potential. Platelets have been shown to facilitate epithelial-mesenchymal transition of tumor cells; neutrophils support tumor adhesion via growth factors such as VEGF and proteases; lymphocytes play a role in modulating the host immune response to malignancy.
The systemic immune-inflammatory index (SII), calculated as (platelet count × neutrophil count) / lymphocyte count, is a relatively new composite marker that reflects immune and inflammatory responses. It has been evaluated as a prognostic biomarker in several cancer-related studies.
Postoperative pain and surgical stress activate systemic inflammatory responses. ESPB is performed as part of postoperative analgesia in patients undergoing breast cancer surgery under general anesthesia, based on voluntary participation. The aim of this study is to evaluate the effect of ESPB on postoperative SII levels in comparison to other analgesia modalities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block | Experimental | Procedure: Erector spinae plane blockPreoperative thoracic level 4 ESP block was applied |
| Control | No intervention | –Group with analgesia provided by Contromal (IM) without blockade |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 18-75 years
- ASA (American Society of Anesthesiologists) physical status I-II-III
- Undergoing unilateral breast cancer surgery under general anesthesia
- Volunteered to participate in the study and signed informed consent
Key exclusion criteria (6 listed)
- Allergy or contraindication to local anesthetics
- Coagulopathy or on anticoagulant therapy
- Infection at the injection site
- History of chronic pain or opioid use
- Neurological or psychiatric disorders affecting pain perception
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 blockThis study aims to compare the effects of erector spinae plane block (ESPB) and systemic tramadol use as postoperative analgesia methods on the systemic immune-inflammatory index (SII) in patients undergoing breast cancer surgery. | Procedure or surgery | Erector spinae plane block |
Primary outcome
Systemic Immune-Inflammation Index (SII)
Time frame: 6 hours postoperatively
Systemic immune-inflammation index (SII) will be calculated using the formula: SII = (Platelet count × Neutrophil count) / Lymphocyte count. This index will be used to evaluate the effect of erector spinae plane block (ESPB) on postoperative systemic inflammation in patients undergoing breast cancer surgery.
1 secondary outcome
Postoperative Pain Score
Time frame: At 0, 2, 4, and 6 hours postoperatively
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 6 May 2025.
- Background: PubMed 32175686He W, Wu Z, Zu L, Sun H, Yang X. Application of erector spinae plane block guided by ultrasound for postoperative analgesia in breast cancer surgery: A randomized controlled trial. Cancer Commun (Lond). 2020 Mar;40(2-3):122-125. doi: 10.1002/cac2.12013. Epub 2020 Mar 16. No abstract available.
- Background: PubMed 31191009Liu J, Shi Z, Bai Y, Liu L, Cheng K. Prognostic significance of systemic immune-inflammation index in triple-negative breast cancer. Cancer Manag Res. 2019 May 14;11:4471-4480. doi: 10.2147/CMAR.S197623. eCollection 2019.
- Derived from this study: PubMed 40958235Gulay E, Gultekin A, Yildirim I, Arar C, Ozkan Gurdal S. Comparison of erector spinae plane block and tramadol on postoperative systemic immune-inflammatory response in breast cancer surgery: A prospective randomized controlled trial. Medicine (Baltimore). 2025 Sep 12;104(37):e44466. doi: 10.1097/MD.0000000000044466.
- Individual participant dataSharing planned: No. Due to privacy and confidentiality concerns, individual participant data (IPD) will not be made available to other researchers. The data will remain confidential, in accordance with institutional and regulatory guidelines.
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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?
A study testing Erector spinae plane block in people with Erector Spinae Plane Block and Systemic Immune-inflammatory Index, run by Namik Kemal University 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?
The sponsor lists 4 inclusion and 6 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: finished, as of the sponsor's last update on 6 May 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 (SII) (time frame: 6 hours postoperatively). 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 NCT06954324, which also lists 3 linked publications.
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 6 May 2025.