Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy (NCT07579650) | Clinical Trial Compass
RecruitingNot Applicable
Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy
Turkey (Türkiye)50 participantsStarted 2026-05-16
Plain-language summary
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
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
24-hour cumulative opioid consumption
Timeframe: 24 hours
Trial details
NCT IDNCT07579650
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital