The Quest for Opioid-Free Analgesia in Reduction Mammoplasty: A Comparative Analysis of PECS, SAP Blocks, and Tumescent Infiltration
The Quest for Opioid-Free Analgesia in Reduction Mammoplasty: A Comparative Analysis of Pectoral Nerve (PECS) Blocks, Serratus Anterior Plane (SAP) Blocks, and Tumescent Infiltration
Reduction mammoplasty is associated with significant early postoperative pain due to the extent of the incision and glandular resection. Effective regional analgesia may reduce opioid requirements; ultrasound-guided pectoral nerve block type II (PECS II), serratus anterior plane block (SAPS) and surgeon-administered local anesthetic wound infiltration.
This is a multi-center, prospective observational study in patients aged 18-70 years (ASA I-III) scheduled for elective reduction mammoplasty. The investigators will compare the two routinely applied techniques with respect to perioperative opioid consumption (primary outcome), postoperative pain scores on the Numeric Rating Scale, total rescue analgesic dose within the first 24 postoperative hours. A minimum of 58 patients will be enrolled based on a priori power analysis. The aim is to determine which of the two existing analgesia protocols better minimizes postoperative analgesic consumption and supports early recovery, in order to inform future pain management protocols.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Reduction mammoplasty is associated with significant early postoperative pain due to the extent of the incision and glandular resection. Effective regional analgesia may reduce opioid requirements and support early recovery, but no single technique has been established as the standard for breast reduction surgery. Two approaches are used routinely at the investigators' institution: ultrasound-guided pectoral nerve block type II (PECS II) with long-acting local anesthetic, and surgeon-administered local anesthetic wound infiltration.
This is a single-center, prospective observational study in patients aged 18-70 years (ASA I-III) scheduled for elective reduction mammoplasty. Both analgesic techniques are part of routine clinical care; no additional intervention, drug, or procedure is applied for study purposes, and the choice of technique is made by the clinical team independently of the study. The investigators will compare the two routinely applied techniques with respect to perioperative opioid consumption (primary outcome), postoperative pain scores on the Numeric Rating Scale, total rescue analgesic dose within the first 24 postoperative hours, incidence and severity of postoperative nausea and vomiting, and length of hospital stay (secondary outcomes). A minimum of 58 patients will be enrolled based on a priori power analysis. The aim is to determine which of the two existing analgesia protocols better minimizes postoperative analgesic consumption and supports early recovery, in order to inform future pain management protocols.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gamze Nur Teke, medical doctor
- Número de teléfono: +905546694389
- Correo electrónico: gamzenur.koca@gmail.com
Ubicaciones de estudio
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şahinbey
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Gaziantep, şahinbey, Turquía (Türkiye), 27072
- Gaziantep City Hospital
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Contacto:
- Gamze Nur Teke, medical doctor
- Número de teléfono: +905546694389
- Correo electrónico: gamzenur.koca@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients scheduled for elective oncoplastic or reconstructive reduction mammoplasty surgery.
- Patients aged between 18 and 70 years.American Society of Anesthesiologists (ASA) physical status classification I, II, or III.
- Patients who voluntarily agree to participate and sign the informed consent form.
Exclusion Criteria:
- Patient refusal to participate in the study or to receive regional anesthesia.
- Active localized infection at the site of the proposed block or surgical area.
- Coagulopathy, bleeding disorders, or patients on active anticoagulant therapy.
- Psychiatric or cognitive disorders that prevent the understanding of the NRS or QoR-15 scoring systems.
- History of revision breast surgery or emergency procedures.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Reduction Mammoplasty
Reduction mammoplasty, also known as breast reduction, is a surgical procedure that removes excess breast tissue, fat, and skin to reduce breast size and weight.
It aims to alleviate physical symptoms like chronic back and neck pain while reshaping the breasts to improve the patient's quality of life.
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pectoral nerve block type II (PECS II): ultrasound guided plane block which is administered local analgesic between pectoserratal and interpectoral muscles
SAPB Block: ultrasound guided plane block which is administered local analgesic into the plane between serratus anterior and intercostal muscles
Tumescent Infiltration Group: Patients will receive standard tumescent infiltration by the surgical team.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total Post-operative Opioid Consumption
Periodo de tiempo: Up to 24 hours post-operatively.
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The total amount of opioid analgesics (converted to intravenous morphine equivalents in milligrams) consumed by the patient via patient-controlled analgesia (PCA) or rescue medication.
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Up to 24 hours post-operatively.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Quality of Recovery-15 (QoR-15) Score
Periodo de tiempo: Baseline (pre-operatively) and at 24 hours post-operatively.
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The QoR-15 is a validated 15-item patient-reported questionnaire used to assess the quality of post-operative recovery.
It evaluates five dimensions of health: emotional state, physical comfort, psychological support, physical independence, and pain.
Each item is scored on a 0-10 scale, yielding a total score ranging from 0 (poor recovery) to 150 (excellent recovery).
Higher scores indicate better quality of recovery.
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Baseline (pre-operatively) and at 24 hours post-operatively.
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Post-operative Pain Intensity (NRS Scores)
Periodo de tiempo: At post-operative 1st, 2nd, 4th, 6th, 12th, and 24th hours.
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Assessment of post-operative pain using the 11-point Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst imaginable pain."
Pain scores will be recorded both at rest and during movement (e.g., arm abduction).
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At post-operative 1st, 2nd, 4th, 6th, 12th, and 24th hours.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of Post-operative Nausea and Vomiting (PONV)
Periodo de tiempo: Up to 24 hours post-operatively.
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The presence or absence of nausea, vomiting, or the need for antiemetic medication will be monitored and recorded as a percentage or scale score.
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Up to 24 hours post-operatively.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Wallace CC, Wetzel ME, Howell C, Vasconez HC. The Efficacy of Pectoralis Nerve Blockade in Breast Reductions: A Prospective Randomized Trial. Ann Plast Surg. 2021 Jun 1;86(6S Suppl 5):S632-S634. doi: 10.1097/SAP.0000000000002763.
- Kerrigan CL, Collins ED, Striplin D, Kim HM, Wilkins E, Cunningham B, Lowery J. The health burden of breast hypertrophy. Plast Reconstr Surg. 2001 Nov;108(6):1591-9. doi: 10.1097/00006534-200111000-00024.
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
- 2026/206
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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