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NCT06954324

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

Completed NA Last updated 6 May 2025
What this trial tests

NA trial testing Erector spinae plane block in Erector Spinae Plane Block in 120 participants. Completed in 1 February 2023.

Timeline
15 March 2021
Primary endpoint
15 March 2022
1 February 2023

Quick facts

Lead sponsorNamik Kemal University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingsingle
Primary purposediagnostic
Enrollment120
Start date15 March 2021
Primary completion15 March 2022
Estimated completion1 February 2023
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Namik Kemal University

Who can join

Adults 18 to 75, female only, with Erector Spinae Plane Block or Systemic Immune-inflammatory Index. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Comparison of erector spinae plane block and tramadol on postoperative systemic immune-inflammatory response in breast cancer surgery: A prospective randomized controlled trial.
    Gülay E, Gültekin A, Yildirim İ, Arar C, et al · · 2025 · PMID 40958235 · DOI 10.1097/md.0000000000044466

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Data sources for this page

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