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

14. Juni 2026 aktualisiert von: 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

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Murat Çelik, Assistant Professor
  • Telefonnummer: +905546902104
  • E-Mail: mucetr@gmail.com

Studieren Sie die Kontaktsicherung

Studienorte

    • Sivas
      • Sivas, Sivas, Türkei (türkiye), 58050
        • Sivas Cumhuriyet University
        • Hauptermittler:
          • Murat Çelik, Assistant Professor
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Onur Avcı, Associate Professor

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
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
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
Aktiver Komparator: 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.
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total Opioid Consumption During the First 24 Hours After Surgery
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Resting Pain Score at 6 Hours After Surgery
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienleiter: Handan Derebaşınlıoğlu, Associate Professor, Cumhuriyet University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

30. Juli 2027

Studienabschluss (Geschätzt)

31. August 2027

Studienanmeldedaten

Zuerst eingereicht

14. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Juni 2026

Zuerst gepostet (Tatsächlich)

18. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

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