An interventional study of Erector spinae plane block in Erector Spinae Plane Block, Systemic Immune-inflammatory Index and Breast Cancer, sponsored by Namik Kemal University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Namik Kemal University · Not applicable, Interventional, and Diagnostic
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Preoperative thoracic level 4 ESP block was applied
Procedure: Erector spinae plane block
Group with analgesia provided by Contromal (IM) without blockade
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.
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.
Time frame: 6 hours postoperatively
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).
Time frame: At 0, 2, 4, and 6 hours postoperatively
Plan to share: 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.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Namik Kemal University