Clinical trial · Interventional
Investigation of the Effect of Erector Spinae Plane Block on Systemic Immuno-Inflammatory Index
Investigation of the Effect of Erector Spinae Plane Block on Systemic Immuno-Inflammatory Index in Breast Cancer Surgery: A Prospective Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Erector Spinae Plane Block | — | UNRESOLVED | — |
| Systemic Immune-inflammatory Index | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erector spinae plane block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erector spinae plane block
- description
- Preoperative thoracic level 4 ESP block was applied
- interventionNames
- Procedure: Erector spinae plane block
- type
- NO_INTERVENTION
- label
- Control
- description
- Group with analgesia provided by Contromal (IM) without blockade
Primary outcomes (1)
- measure
- Systemic Immune-Inflammation Index (SII)
- timeFrame
- 6 hours postoperatively
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (3)
- BACKGROUNDHe 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. PMID 32175686
- BACKGROUNDLiu 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. PMID 31191009
- DERIVEDGulay 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. PMID 40958235