Clinical Trials Directory

Trials / Completed

CompletedNCT06954324

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

Investigation of the Effect of Erector Spinae Plane Block on Systemic Immuno-Inflammatory Index in Breast Cancer Surgery: A Prospective Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Namik Kemal University · Academic / Other
Sex
Female
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREErector spinae plane blockThis 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.

Timeline

Start date
2021-03-15
Primary completion
2022-03-15
Completion
2023-02-01
First posted
2025-05-01
Last updated
2025-05-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06954324. Inclusion in this directory is not an endorsement.