- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07601490
The Effect of Nerve Blocks on Analgesia in Breast Cancer Surgery (breast surgery)
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
Estado
Condiciones
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
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dilek Metin Yamac, MD
- Número de teléfono: +905054959792
- Correo electrónico: ddilekmetin@hotmail.com
Ubicaciones de estudio
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Uskudar
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Istanbul, Uskudar, Turquía (Türkiye), 34668
- Health Sciences University 2. Sultan Abdülhamid Han Training and Research Hospital
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Contacto:
- Dilek Metin Yamac, Medicine Doctor
- Número de teléfono: +90216 542 20 00
- Correo electrónico: ddilekmetin@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
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
¿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 |
|---|---|
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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.
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Ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.
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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.
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Ultrasound-guided Serratus Anterior Plane (SAP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative pain intensity assessed by Visual Analog Scale (VAS)
Periodo de tiempo: At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery
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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.
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At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intraoperative remifentanil consumption
Periodo de tiempo: During surgery
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Total intraoperative remifentanil consumption will be recorded and compared between the SPSIP block group and SAP block group.
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During surgery
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Total postoperative tramadol consumption within 24 hours
Periodo de tiempo: First 24 hours after surgery
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Total tramadol consumption during the first 24 postoperative hours will be recorded to evaluate postoperative opioid requirements in both groups.
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First 24 hours after surgery
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Postoperative nausea and vomiting (PONV) scores
Periodo de tiempo: First 24 hours after surgery
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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.
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First 24 hours after surgery
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Arik E, Zengin M, Seker G, Kucuk O, Gungordu E, Ozguner Y, Alagoz A, Ergil J. Is the serratus posterior superior intercostal plane block a viable alternative to the erector spinae plane block for postoperative analgesia in breast surgery? A prospective, randomized trial. BMC Anesthesiol. 2025 Nov 29;26(1):11. doi: 10.1186/s12871-025-03531-y.
- Baytar C, Aktas B, Aydin BG, Piskin O, Cakmak GK, Ayoglu H. The effects of ultrasound-guided serratus anterior plane block on intraoperative opioid consumption and hemodynamic stability during breast surgery: A randomized controlled study. Medicine (Baltimore). 2022 Sep 2;101(35):e30290. doi: 10.1097/MD.0000000000030290.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- SBU-ANESTEZİ-DMY-05
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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Goztepe Prof Dr Suleyman Yalcın City HospitalTerminadoCirugía artroscópica de hombroTurquía (Türkiye)
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Saglik Bilimleri Universitesi Gazi Yasargil Training...TerminadoEl manejo del dolor | IVA | Bloques de PlanoTurquía (Türkiye)
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Tanta UniversityTerminadoAnalgesia | Bloqueo del nervio supraescapular | Cirugía artroscópica de hombro | Bloqueo del nervio axilar | Bloqueo del plano intercostal superior posterior del serratoEgipto
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Zonguldak Bulent Ecevit UniversityActivo, no reclutando
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Cumhuriyet UniversityTerminado
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Atatürk Chest Diseases and Chest Surgery Training...ReclutamientoDolor Postoperatorio | Bloque del plano anterior del serrato | Cirugía Torácica, Video-Asistida | Anestesia localPavo
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Tanta UniversityTerminado
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Ankara City Hospital BilkentTerminadoManejo del dolor postoperatorio | Cirugía cardíaca mínimamente invasiva | Enfermedad valvular del corazón | Bloqueo del plano intercostal superior posterior del serratoTurquía (Türkiye)
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Diskapi Yildirim Beyazit Education and Research...TerminadoNeoplasias de mama | Dolor Postoperatorio | Dolor agudo | Bloque plano del erector de la columna | Bloqueo del plano intercostal superior posterior del serratoPavo
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Halil Ibrahim AltunReclutamiento