Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SPSIP Block With Bupivacaine, SPSIP Block With Saline.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mastectomy and Axillary Dissection: Evaluation of the Effect of Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia: A Multicenter, Randomized, Placebo-Controlled Trial
Overview
This study aims to evaluate the effect of serratus posterior superior intercostal plane (SPSIP) block on postoperative pain, opioid consumption, and analgesic requirements in patients undergoing mastectomy and axillary lymph node dissection
Detailed description
This study is a prospective, randomized, placebo-controlled, multicenter clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing mastectomy with axillary lymph node dissection. Postoperative pain following breast surgery is often significant and may increase opioid consumption and related adverse effects, highlighting the need for effective regional anesthesia techniques.
The SPSIP block is a novel ultrasound-guided interfascial plane block with emerging evidence in thoracic and chest wall procedures; however, its role in breast surgery remains unclear, particularly in placebo-controlled settings. This study aims to determine whether the SPSIP block provides additional benefit as part of a standardized multimodal analgesia approach.
Participants will be randomly assigned to receive either SPSIP block with local anesthetic or a placebo intervention under identical conditions, with blinding applied to all relevant parties. All patients will receive the same perioperative anesthesia and analgesia protocol.
The results of this study are expected to clarify the clinical value of SPSIP block in breast surgery and contribute to the development of evidence-based postoperative pain management strategies.
Interventions
- Procedure SPSIP Block With Bupivacaine
Participants will receive an ultrasound-guided SPSIP block using bupivacaine. - Procedure SPSIP Block With Saline
Participants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions.
Primary outcome measures
- 24-hour cumulative opioid consumption [Time frame: 24 hours]
Secondary outcome measures (7)
- Static postoperative pain intensity at rest [Time frame: 0, 1, 2, 6, 12, and 24 hours after surgery]
- Dynamic postoperative pain intensity during movement [Time frame: 0, 1, 2, 6, 12, and 24 hours after surgery]
- Rescue analgesia requirement [Time frame: Within 24 hours after surgery]
- Time to first rescue analgesia [Time frame: Within 24 hours after surgery]
- Incidence of postoperative nausea and vomiting (PONV) [Time frame: Within 24 hours after surgery]
- Quality of Recovery-15 (QoR-15) score [Time frame: 24 hours after surgery]
- Block-related and opioid-related adverse events [Time frame: Within 24 hours after surgery]
Eligibility criteria
Inclusion criteria
- Female patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective unilateral mastectomy with axillary lymph node dissection under general anesthesia
- Able to understand and use the Numeric Rating Scale (NRS) for pain assessment
- Provided written informed consent
Exclusion criteria
- Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
- Coagulopathy, thrombocytopenia (<100,000/mm³), or ongoing anticoagulant/antiplatelet therapy that cannot be discontinued
- Infection or skin lesion at the injection site
- Planned bilateral surgery or additional major surgical procedures
- Chronic pain conditions or regular use of opioids, gabapentinoids, or centrally acting analgesics
- Neurological or psychiatric conditions interfering with pain assessment
- History of previous major thoracic or chest wall surgery on the same side
- Pregnancy or breastfeeding
- Refusal to participate or inability to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Fatma Acil — Diyarbakır
Identifiers
NCT: NCT07579650 · 27/01/2026-38