About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block
Procedure/SurgeryBilateral ultrasound-guided serratus posterior superior intercostal plane block will be performed after induction of general anesthesia and before surgical local anesthetic infiltration and skin incision.
Standard Perioperative Pain Treatment
Other interventionParticipants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed.
Treatment groups
Trial outcomes
Primary outcomes
Total Opioid Consumption During the First 24 Hours After Surgery
Total opioid consumption will be calculated from all rescue opioid analgesics administered during the first 24 hours after surgery. Opioid use will be obtained from medication administration records and reported as intravenous morphine equivalent dose in milligrams. Higher values indicate greater opioid consumption.
Secondary outcomes
Resting Pain Score at 6 Hours After Surgery
Pain intensity at rest will be assessed using the 0 to 10 Numeric Rating Scale. A score of 0 indicates no pain, and a score of 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
Time to First Rescue Analgesic Requirement
The time from the end of surgery to the first administration of rescue analgesic medication will be recorded. Longer time indicates longer duration before additional analgesic treatment is needed.
Number of Participants With Postoperative Nausea, Vomiting, or Additional Antiemetic Requirement During the First 24 Hours
The number of participants who develop postoperative nausea, vomiting, or require additional antiemetic medication during the first 24 hours after surgery will be recorded. This outcome will be assessed as present or absent for each participant.
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