SPSIP Block for Pain Control After Breast Reduction Surgery (NCT07657949) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
SPSIP Block for Pain Control After Breast Reduction Surgery
Turkey (Türkiye)80 participantsStarted 2026-08-01
Plain-language summary
The goal of this clinical trial is to learn whether an ultrasound-guided serratus posterior superior intercostal plane block (SPSIP block) can lower the need for opioid pain medicine after breast reduction surgery.
The main question it aims to answer is: Does adding an SPSIP block to standard anesthesia and pain treatment lower opioid use during the first 24 hours after surgery? Researchers will compare participants who receive standard anesthesia and pain treatment with participants who receive standard anesthesia and pain treatment plus an SPSIP block.
Participants will:
* Have planned bilateral breast reduction surgery under general anesthesia
* Be randomly assigned to the SPSIP block group or the control group
* Receive standard local anesthetic infiltration during surgery and standard pain treatment after surgery
* Have their pain score and pain medicine use recorded during the first 24 hours after surgery
* Be followed for safety and complications for 30 days after surgery
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 participants aged 18 to 65 years
* Scheduled for elective bilateral reduction mammaplasty
* Planned surgery under general anesthesia
* American Society of Anesthesiologists physical status class I to III
* Planned postoperative clinical follow-up for the first 24 hours after surgery
* Able to understand and report pain using the 0 to 10 Numeric Rating Scale
* Able to provide written informed consent for study participation
Exclusion Criteria:
* Known allergy or hypersensitivity to local anesthetic drugs
* Contraindication to regional anesthesia or fascial plane block
* Coagulopathy or clinically significant bleeding disorder
* Use of anticoagulant or antiplatelet medication that prevents safe block application
* Infection at the planned block injection site
* Chronic opioid use, chronic pain syndrome, or regular analgesic use that may affect postoperative pain assessment
* Revision breast surgery
* Planned major additional surgical procedure other than reduction mammaplasty
* Pregnancy or lactation
* Unable to reliably report pain scores
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.
1This trial is testing a nerve block called SPSIP specifically to reduce opioid use in the first 24 hours after breast reduction surgery — how does this nerve block work, and would it be relevant to my planned procedure?
2Since this trial hasn't started recruiting yet, is there a realistic chance it will be up and running before my surgery is scheduled, or should I be planning around currently available pain management options?
3The main thing this study is measuring is total opioid consumption in the first 24 hours after surgery — does that mean the safety and longer-term pain control benefits of this nerve block are still uncertain, and how does that affect whether it might be right for me?
4Are there already established nerve block or non-opioid pain control techniques used for breast reduction that my care team currently offers, and how do those compare to what this trial is testing?
5If this trial is listed as 'Phase NA,' what does that tell us about how much clinical evidence already exists for this specific nerve block technique in breast surgery, and is that something we should weigh carefully before considering participation?
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
Total Opioid Consumption During the First 24 Hours After Surgery
Timeframe: From the end of surgery to 24 hours after surgery