Investigation of the Effect of Erector Spinae Plane Block on Systemic Immuno-Inflammatory Index

Namik Kemal University

Status: Completed

Conditions: Breast Cancer; Systemic Immune-inflammatory Index; Erector Spinae Plane Block

Treatments: Procedure: Erector spinae plane block

Study type: Interventional

Funder types: Other

Identifiers

NCT06954324

NamikKU-AGultekin-Ezgi2025

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Erector spinae plane block

Experimental group

Description:

Preoperative thoracic level 4 ESP block was applied

Treatment:

Procedure: Erector spinae plane block

Control

No Intervention group

Description:

Group with analgesia provided by Contromal (IM) without blockade