EFFECTS OF SPSIP BLOCK ON PERIOPERATİVE INFLAMMATION AND TLR4 IN BREAST CANCER SURGERY

Mucahide Emine Fidancı Kuas80 enrolled

Overview

This study will investigate whether the serratus posterior superior intercostal plane (SPSIP) block improves postoperative recovery after breast cancer surgery. Participants will be randomly assigned to one of two groups. One group will receive an ultrasound-guided SPSIP block, while the other group will undergo a similar procedure without active medication (sham procedure). Both groups will receive standard general anesthesia and postoperative pain management. Postoperative pain intensity, need for additional pain medication, nausea and vomiting, length of hospital stay, and persistent pain at 3 months after surgery will be assessed. Blood samples collected before surgery and at predetermined postoperative time points will be used to evaluate the body's inflammatory response to surgery and innate immune system activity. These assessments will include toll-like receptor 4 (TLR4), an immune-system marker, and selected inflammatory markers. The main question of this study is whether the SPSIP block, compared with the sham procedure, reduces the surgery-related inflammatory response and improves postoperative pain outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Breast Cancer

Interventions

Serratus posterior superior intercostal plane blockPROCEDURE

The SPSIP block will be performed preoperatively in the sitting position under ultrasound guidance using a linear 6-13 MHz transducer and an in-plane needle approach. Local anesthetic will be injected into the serratus posterior superior intercostal plane according to the study protocol.

Sham SPSIP ProcedurePROCEDURE

A simulated ultrasound-guided SPSIP procedure will be performed in the sitting position using the same positioning and ultrasound preparation as the SPSIP block group, but no local anesthetic will be injected.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients aged 18 to 85 years. * Scheduled for elective breast cancer surgery under general anesthesia. * American Society of Anesthesiologists (ASA) physical status I-III. * Able to provide written informed consent. Exclusion Criteria: * Refusal to participate or inability to provide informed consent. * Allergy or contraindication to the study local anesthetic. * Coagulopathy or ongoing anticoagulant treatment contraindicating regional anesthesia. * Infection at the planned injection site. * Pre-existing chronic pain condition or regular opioid use. * Inability to communicate pain scores or comply with study assessments.

Outcomes

Primary Outcomes

Change in serum TLR4 concentration from baseline to 24 hours after surgery

Serum Toll-like receptor 4 (TLR4) concentration will be measured by ELISA before the intervention (baseline, T0) and 24 hours after surgery (T4). The primary outcome is the change in TLR4 concentration between T0 and T4, compared between the SPSIP block and sham-control groups.

Time frame: Baseline (preoperative) to 24 hours after surgery