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

14 giugno 2026 aggiornato da: 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

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Murat Çelik, Assistant Professor
  • Numero di telefono: +905546902104
  • Email: mucetr@gmail.com

Backup dei contatti dello studio

  • Nome: Handan Derebaşınlıoğlu, Associate Professor
  • Numero di telefono: (0346) 258 00 00
  • Email: hastane@cumhuriyet.edu.tr

Luoghi di studio

    • Sivas
      • Sivas, Sivas, Turchia (Türkiye), 58050
        • Sivas Cumhuriyet University
        • Investigatore principale:
          • Murat Çelik, Assistant Professor
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Onur Avcı, Associate Professor

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • 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.
Altri nomi:
  • Standard anesthesia and postoperative analgesia
Comparatore attivo: 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.
Altri nomi:
  • Standard anesthesia and postoperative analgesia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Opioid Consumption During the First 24 Hours After Surgery
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Resting Pain Score at 6 Hours After Surgery
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Handan Derebaşınlıoğlu, Associate Professor, Cumhuriyet University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

30 luglio 2027

Completamento dello studio (Stimato)

31 agosto 2027

Date di iscrizione allo studio

Primo inviato

14 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 giugno 2026

Primo Inserito (Effettivo)

18 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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