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NCT Number: NCT07843212

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

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.

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Key information

Conditions

Serratus Posterior Superior Intercostal Plane Block (SPSIPB) Breast Cancer Breast Diseases Breast Neoplasms Macular Degeneration, Age-Related, 10 Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Toll-like Receptors

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hitit University Erol Olçok Training and Research Hospital

Çorum, 19040, Turkey (Türkiye)

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Serratus Posterior Superior Intercostal Plane Block

Procedure

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

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.

Primary outcomes

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

    Time frame: 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Mucahide Emine Fidancı Kuas

Other

Registry information

Official study 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

Acronym: SPSIP-TLR4

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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