Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Serratus Posterior Superior Intercostal Plane Block (SPSIPB) | — | UNRESOLVED | — |
| Toll-Like Receptors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Serratus posterior superior intercostal plane block | Procedure | — | UNRESOLVED |
| Sham SPSIP Procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SPSIP Block Group
- description
- Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with local anesthetic before induction of general anesthesia, in addition to standardized general anesthesia and postoperative analgesia.
- interventionNames
- Procedure: Serratus posterior superior intercostal plane block
- type
- SHAM_COMPARATOR
- label
- Sham Block Group
- description
- Participants will undergo a simulated ultrasound-guided SPSIP procedure without local anesthetic injection before induction of general anesthesia, in addition to standardized general anesthesia and postoperative analgesia.
- interventionNames
- Procedure: Sham SPSIP Procedure
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available