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NCT07843212From ClinicalTrials.govRecruiting

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

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

  • Serratus Posterior Superior Intercostal Plane Block (SPSIPB)
  • Breast Cancer
  • Toll-Like Receptors

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Mucahide Emine Fidancı Kuas
Enrolment target
80
Started
14 July 2026
Main results due
30 January 2027
Study sites
1
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 85 years.
  • Women only.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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 sites(1)

  • Hitit University Erol Olçok Training and Research Hospital

    Çorum, Çorum, Turkey (Türkiye)

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07843212. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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