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SPSIP Block for Pain Control After Breast Reduction Surgery (SPSIP-RM)

23 augustus 2026 bijgewerkt door: Murat Çelik, Cumhuriyet University Hospital

Effect of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block on Opioid Consumption After Reduction Mammaplasty: A Prospective Randomized Controlled 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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Reduction mammaplasty, also known as breast reduction surgery, may be associated with early postoperative pain because it is usually performed bilaterally and involves wide surgical dissection and tissue resection. Multimodal pain treatment is commonly used after this procedure to provide adequate pain control and to limit opioid exposure.

The serratus posterior superior intercostal plane block (SPSIP block) is an ultrasound-guided fascial plane block used for thoracic wall analgesia. Recent studies have evaluated this block in breast surgery, but data specific to reduction mammaplasty remain limited. In routine practice, surgical local anesthetic infiltration is often used during reduction mammaplasty. Therefore, this trial will evaluate whether adding bilateral SPSIP block to standard anesthesia, surgical local infiltration, and standard postoperative pain treatment provides additional opioid-sparing benefit.

This study is designed as a prospective, randomized, parallel-group, assessor-blinded, single-center clinical trial. Participants scheduled for elective bilateral reduction mammaplasty will be assigned in a 1:1 ratio to either the SPSIP block group or the control group. In the SPSIP block group, bilateral SPSIP block will be performed under ultrasound guidance after induction of general anesthesia and before surgical local infiltration and skin incision. The control group will not receive SPSIP block.

Both groups will receive the same standardized general anesthesia, surgical local anesthetic infiltration, postoperative multimodal analgesia, and rescue analgesia protocol. The local anesthetic agent, concentration, volume, and maximum safe dose limits for the block and surgical infiltration will be standardized before study enrollment.

The trial is planned to reflect routine plastic surgery practice. Surgical technique, pedicle selection, resection amount, drain use, and the use of dermal graft or internal support when clinically needed will be decided by the surgical team according to participant anatomy and routine clinical judgment. These variables will be recorded to describe surgical variability and may be considered in additional analyses if needed.

Postoperative pain assessments will be performed by ward nurses who are blinded to group allocation. Opioid use will be obtained from medication administration records. Block-related events and surgical complications will be recorded during routine postoperative care and up to 30 days after surgery.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Murat Çelik, Assistant Professor
  • Telefoonnummer: +905546902104
  • E-mail: mucetr@gmail.com

Studie Contact Back-up

Studie Locaties

  • Turkije (Türkiye)
    • Sivas
      • Sivas, Sivas, Turkije (Türkiye), 58050
        • Werving
        • Sivas Cumhuriyet University
        • Hoofdonderzoeker:
          • Murat Çelik, Assistant Professor
        • Onderonderzoeker:
          • Handan Derebaşınlıoğlu, Associate Professor
        • Contact:
        • Contact:
        • Onderonderzoeker:
          • Onur Avcı, Associate Professor

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: SPSIP Block Group
Participants in this arm will receive bilateral ultrasound-guided serratus posterior superior intercostal plane block after induction of general anesthesia and before surgical local infiltration and skin incision. They will also receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment.
Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block
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.
Andere namen:
  • SPSIP block
Ander: Standard Perioperative Pain Treatment
Participants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed.
Andere namen:
  • Standard anesthesia and postoperative analgesia
Actieve vergelijker: Control Group
Participants in this arm will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment. They will not receive serratus posterior superior intercostal plane block.
Ander: Standard Perioperative Pain Treatment
Participants will receive standard general anesthesia, standardized surgical local anesthetic infiltration, and standard postoperative multimodal pain treatment with rescue analgesia when clinically needed.
Andere namen:
  • Standard anesthesia and postoperative analgesia

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total Opioid Consumption During the First 24 Hours After Surgery
Tijdsspanne: From the end of surgery to 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.
From the end of surgery to 24 hours after surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Resting Pain Score at 6 Hours After Surgery
Tijdsspanne: 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.
6 hours after surgery
Time to First Rescue Analgesic Requirement
Tijdsspanne: From the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgery
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.
From the end of surgery to the first rescue analgesic administration, assessed up to 24 hours after surgery
Number of Participants With Postoperative Nausea, Vomiting, or Additional Antiemetic Requirement During the First 24 Hours
Tijdsspanne: From the end of surgery to 24 hours after surgery
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.
From the end of surgery to 24 hours after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Cumhuriyet University Hospital

Onderzoekers

  • Studie directeur: Handan Derebaşınlıoğlu, Associate Professor, Cumhuriyet University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 augustus 2026

Primaire voltooiing (Geschat)

31 augustus 2027

Studie voltooiing (Geschat)

30 september 2027

Studieregistratiedata

Eerst ingediend

14 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 juni 2026

Eerst geplaatst (Werkelijk)

18 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

23 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 26_06_04_35

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared because the study data contain clinical and perioperative information from surgical participants and sharing individual-level data was not included in the ethics approval or informed consent process.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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