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The Effect of Nerve Blocks on Analgesia in Breast Cancer Surgery (breast surgery)

22 de mayo de 2026 actualizado por: Dilek Yamac, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Comparison of Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in Modified Radical Mastectomy Surgery

Postoperative pain following modified radical mastectomy remains a significant clinical concern and may adversely affect patient recovery, opioid consumption, and overall patient satisfaction. Ultrasound-guided regional anesthesia techniques have gained increasing importance as part of multimodal analgesia strategies in breast surgery. The serratus anterior plane (SAP) block is a commonly used interfascial plane block for postoperative analgesia in thoracic and breast procedures. Recently, the serratus posterior superior intercostal plane (SPSIP) block has emerged as a novel regional anesthesia technique with potentially wider thoracic dermatomal spread and effective analgesic properties.

This prospective randomized controlled study aims to compare the postoperative analgesic efficacy of the SPSIP block and SAP block in patients undergoing modified radical mastectomy under general anesthesia. Patients will be randomly allocated into two groups to receive either ultrasound-guided SPSIP block or SAP block preoperatively. Primary outcomes will include postoperative pain scores and opioid consumption within the first 24 hours after surgery. Secondary outcomes will include time to first analgesic request, rescue analgesic requirements, intraoperative hemodynamic parameters, postoperative nausea and vomiting, block-related complications, and patient satisfaction.

The study is designed to evaluate whether SPSIP block provides superior postoperative analgesia compared with SAP block in modified radical mastectomy surgery.

Descripción general del estudio

Descripción detallada

This prospective, randomized, controlled clinical study is designed to compare the postoperative analgesic efficacy of the ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block and Serratus Anterior Plane (SAP) block in patients undergoing modified radical mastectomy under general anesthesia. Postoperative pain after breast cancer surgery remains an important clinical problem and may negatively affect respiratory function, early mobilization, recovery quality, patient satisfaction, and postoperative opioid consumption. Effective perioperative analgesia is therefore an essential component of enhanced recovery protocols in breast surgery.

Regional anesthesia techniques have increasingly been incorporated into multimodal analgesia strategies to reduce opioid-related adverse effects and improve postoperative pain control. The SAP block is widely used in breast and thoracic surgery due to its ability to provide analgesia to the lateral thoracic wall through blockade of the lateral cutaneous branches of the intercostal nerves. However, recently described fascial plane blocks such as the SPSIP block may provide broader dermatomal spread and more effective thoracic analgesia. Despite growing interest in the SPSIP block, evidence regarding its analgesic efficacy in breast surgery remains limited.

The study will include adult female patients scheduled for elective modified radical mastectomy under general anesthesia. Following enrollment and randomization, patients will be allocated to receive either ultrasound-guided SPSIP block or SAP block preoperatively in addition to standardized general anesthesia and multimodal analgesia protocols. All regional blocks will be performed under sterile conditions using ultrasound guidance by experienced anesthesiologists. Standard intraoperative monitoring will be applied throughout the surgical procedure.

Perioperative anesthetic management will be standardized as much as possible to minimize confounding factors affecting postoperative pain outcomes. Intraoperative opioid administration, hemodynamic parameters, and anesthetic requirements will be recorded. Postoperative analgesia protocols, including rescue analgesic administration criteria, will also be standardized for all participants.

The primary aim of the study is to evaluate and compare postoperative analgesic effectiveness between SPSIP and SAP blocks. Analgesic efficacy will be assessed using postoperative pain scores at predefined time intervals and cumulative opioid consumption during the postoperative period. Additional perioperative parameters related to recovery and analgesic quality will also be evaluated to determine the clinical utility of these interfascial plane blocks in breast surgery.

This study is expected to contribute to the current literature regarding novel regional anesthesia techniques for breast surgery and may help define the role of SPSIP block as an alternative or superior analgesic approach compared with SAP block in modified radical mastectomy patients.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

70

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Uskudar
      • Istanbul, Uskudar, Turquía (Türkiye), 34668
        • Health Sciences University 2. Sultan Abdülhamid Han Training and Research Hospital
        • Contacto:
          • Dilek Metin Yamac, Medicine Doctor
          • Número de teléfono: +90216 542 20 00
          • Correo electrónico: ddilekmetin@hotmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Female patients aged between 18 and 65 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Body Mass Index (BMI) <35 kg/m²
  • Normal International Normalized Ratio (INR) value and platelet count
  • Normal liver and renal function tests
  • Patients scheduled for elective modified radical mastectomy surgery

Exclusion Criteria:

  • Bleeding diathesis
  • Allergy to local anesthetic agents
  • Suspected infection or inflammation at the planned block site
  • ASA physical status IV or higher
  • Long-term medication use due to chronic pain
  • Advanced hepatic or renal failure
  • Presence of severe pulmonary disease
  • Use of any opioid medication within 24 hours before surgery
  • Cognitive impairment
  • Patients undergoing revision surgery

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Serratus Posterior Superior Intercostal Plane (SPSIP) block
Participants assigned to this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block before induction of general anesthesia for modified radical mastectomy surgery. The block will be performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance. Following the regional block procedure, standardized general anesthesia and postoperative multimodal analgesia protocols will be applied. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be recorded and evaluated.
Ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.
Comparador activo: Serratus Anterior Plane (SAP) block
Participants assigned to this group will receive an ultrasound-guided Serratus Anterior Plane (SAP) block before induction of general anesthesia for modified radical mastectomy surgery. The block will be performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance. Following the regional block procedure, standardized general anesthesia and postoperative multimodal analgesia protocols will be applied. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be recorded and evaluated.
Ultrasound-guided Serratus Anterior Plane (SAP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative pain intensity assessed by Visual Analog Scale (VAS)
Periodo de tiempo: At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst imaginable pain." VAS scores at rest and during movement will be recorded and compared between patients receiving ultrasound-guided superior posterior serratus intercostal plane (SPSIP) block and serratus anterior plane (SAP) block following modified radical mastectomy surgery. Higher VAS scores indicate greater pain severity and poorer analgesic efficacy.
At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Intraoperative remifentanil consumption
Periodo de tiempo: During surgery
Total intraoperative remifentanil consumption will be recorded and compared between the SPSIP block group and SAP block group.
During surgery
Total postoperative tramadol consumption within 24 hours
Periodo de tiempo: First 24 hours after surgery
Total tramadol consumption during the first 24 postoperative hours will be recorded to evaluate postoperative opioid requirements in both groups.
First 24 hours after surgery
Postoperative nausea and vomiting (PONV) scores
Periodo de tiempo: First 24 hours after surgery
Postoperative nausea and vomiting will be assessed using a standardized Postoperative Nausea and Vomiting (PONV) severity scale ranging from 0 to 3, where 0 indicates no nausea or vomiting, 1 indicates mild nausea, 2 indicates severe nausea or a single episode of vomiting, and 3 indicates multiple episodes of vomiting. PONV scores will be recorded and compared between groups during the postoperative period. Higher scores indicate more severe postoperative nausea and vomiting and therefore worse clinical outcomes.
First 24 hours after surgery

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de junio de 2026

Finalización primaria (Estimado)

15 de octubre de 2026

Finalización del estudio (Estimado)

16 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

15 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Serratus Posterior Superior Intercostal Plane Block

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