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.
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.
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.
Parallel
Serratus posterior superior intercostal plane block
Procedure/SurgeryThe 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
Procedure/SurgeryA 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.
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.
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Mucahide Emine Fidancı Kuas
Lead sponsor
Erol Olcok Corum Training and Research Hospital
Sponsor institution
