SPSIP Block for Pain Control After Breast Reduction Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorCumhuriyet University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

    Procedure/Surgery

    Bilateral 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 intervention

    Participants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: SPSIP Block GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From the end of surgery to 24 hours after surgery

Secondary outcomes

1

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 frame
6 hours after surgery
2

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.

Time frame
From the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgery
3

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.

Time frame
From the end of surgery to 24 hours after surgery

Other outcomes

Sponsors and contacts

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