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临床试验/NCT06954324
NCT06954324已完成不适用

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

Namik Kemal University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Systemic Immune-Inflammation Index (SII)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Erector spinae plane block

Experimental

Preoperative thoracic level 4 ESP block was applied

干预措施: Erector spinae plane block (Procedure)

Control

No Intervention

Group with analgesia provided by Contromal (IM) without blockade

结局指标

主要结局

Systemic Immune-Inflammation Index (SII)

时间窗: 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.

次要结局

  • Postoperative Pain Score(At 0, 2, 4, and 6 hours postoperatively)

研究者

发起方
Namik Kemal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet Gültekin

Associate Professor

Namik Kemal University

研究点 (1)

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