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

May 2, 2025 updated by: Ahmet Gültekin, Namik Kemal University

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tekirdağ, Turkey, 59020
        • Namik Kemal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erector spinae plane block
Preoperative thoracic level 4 ESP block was applied
Procedure: Erector spinae plane block
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.
No Intervention: Control
Group with analgesia provided by Contromal (IM) without blockade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score
Time Frame: At 0, 2, 4, and 6 hours postoperatively
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).
At 0, 2, 4, and 6 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namik Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NamikKU-AGultekin-Ezgi2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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