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

23 août 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Murat Çelik, Assistant Professor
  • Numéro de téléphone: +905546902104
  • E-mail: mucetr@gmail.com

Sauvegarde des contacts de l'étude

  • Nom: Handan Derebaşınlıoğlu, Associate Professor
  • Numéro de téléphone: (0346) 258 00 00
  • E-mail: hastane@cumhuriyet.edu.tr

Lieux d'étude

  • Turquie (Türkiye)
    • Sivas
      • Sivas, Sivas, Turquie (Türkiye), 58050
        • Recrutement
        • Sivas Cumhuriyet University
        • Chercheur principal:
          • Murat Çelik, Assistant Professor
        • Sous-enquêteur:
          • Handan Derebaşınlıoğlu, Associate Professor
        • Contact:
        • Contact:
          • Onur Avcı, Associate Professor
          • Numéro de téléphone: 90 530 112 64 08
          • E-mail: dronuravci@gmail.com
        • Sous-enquêteur:
          • Onur Avcı, Associate Professor

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: 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.
Autres noms:
  • SPSIP block
Autre: 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.
Autres noms:
  • Standard anesthesia and postoperative analgesia
Comparateur actif: 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.
Autre: 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.
Autres noms:
  • Standard anesthesia and postoperative analgesia

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Total Opioid Consumption During the First 24 Hours After Surgery
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Resting Pain Score at 6 Hours After Surgery
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cumhuriyet University Hospital

Les enquêteurs

  • Directeur d'études: Handan Derebaşınlıoğlu, Associate Professor, Cumhuriyet University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

24 août 2026

Achèvement primaire (Estimé)

31 août 2027

Achèvement de l'étude (Estimé)

30 septembre 2027

Dates d'inscription aux études

Première soumission

14 juin 2026

Première soumission répondant aux critères de contrôle qualité

14 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 26_06_04_35

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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