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

NCT06954324 | Completed

• 1 other identifier: NamikKU-AGultekin-Ezgi2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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

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

Keywords

Breast cancer; Systemic immune inflammatory index (SII); Erector spinae plane block (ESPB); Stress response

Outcome Measures

Primary Outcomes (1)

• 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.

  6 hours postoperatively

Secondary Outcomes (1)

• Postoperative Pain Score

  At 0, 2, 4, and 6 hours postoperatively

Study Arms (2)

Erector spinae plane block

EXPERIMENTAL

Preoperative thoracic level 4 ESP block was applied

Procedure: Erector spinae plane block

Control

NO INTERVENTION

Group with analgesia provided by Contromal (IM) without blockade

Interventions

Erector spinae plane block PROCEDURE

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.

Erector spinae plane block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female (because it is a breast cancer study)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Namik Kemal University

Tekirdağ, 59020, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 32175686 BACKGROUND

• Liu 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 BACKGROUND

• Gulay 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Fractures, Stress

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 1, 2025
• Study Start: March 15, 2021
• Primary Completion: March 15, 2022
• Study Completion: February 1, 2023
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)