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NCT07657949
SPSIP Block for Pain Control After Breast Reduction Surgery
Conditions: Postoperative Pain Breast Reduction, Mammaplasty, Analgesia, Nerve Block, Opioid Consumption, Postoperative
Sex: Female
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Cumhuriyet University Hospital
Location: Sivas Cumhuriyet University Sivas Sivas
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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07657949). StuddyBuddy aggregates publicly available trial information.