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RECRUITING
NCT07843212
NA

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

Sponsor: Mucahide Emine Fidancı Kuas

View on ClinicalTrials.gov

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.

Official title: EFFECTS OF SERRATUS POSTERIOR SUPERIOR INTERCOSTAL PLANE BLOCK ON PERIOPERATIVE INFLAMMATORY RESPONSE AND TLR-4 MEDİATED INNATE IMMUNE ACTIVATION IN BREAST CANCER SURGERY: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, SHAM-CONTROLLED TRIAL

Key Details

Gender

FEMALE

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-07-14

Completion Date

2027-01-30

Last Updated

2026-09-25

Healthy Volunteers

Yes

Interventions

PROCEDURE

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.

PROCEDURE

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.

Locations (1)

Hitit University Erol Olçok Training and Research Hospital

Çorum, Çorum, Turkey (Türkiye)