Effects of SPSIP Block on Perioperative Inflammation and TLR4 in Breast Cancer Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Serratus posterior superior intercostal plane block: 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 Procedure: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in serum TLR4 concentration from baseline to 24 hours after surgery — Baseline (preoperative) 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.

Trial sites (1)

Other trials for the same condition