SPSIP block to help pain after mastectomy with lymph node removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, placebo-controlled, multicenter trial evaluating the analgesic effect of the SPSIP block in women undergoing unilateral mastectomy with axillary lymph node dissection. Participants are randomly assigned to receive either SPSIP block with bupivacaine or a saline placebo, in addition to a standardized multimodal analgesia plan, with blinding of patients and investigators. The study aims to determine if the SPSIP block provides additional pain relief and reduces analgesic needs compared with placebo. Outcomes focus on postoperative pain scores, opioid consumption, and analgesic requirements. The trial addresses whether SPSIP can be advantageous in breast surgery within modern pain-management strategies.

Why it matters

Who can join: the full rules

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

Where it's running

• Fatma Acil
  Diyarbakır, Outside of the US, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Fatma Acil, M.D. — Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• Study coordinator: Fatma Acil, M.D.
• Email: acilfatma@gmail.com
• Phone: +905337225225

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.