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.
Visão geral do estudo
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Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Gamze Nur Teke, medical doctor
- Número de telefone: +905546694389
- E-mail: gamzenur.koca@gmail.com
Locais de estudo
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şahinbey
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Gaziantep, şahinbey, Turquia (Türkiye), 27072
- Gaziantep City Hospital
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Contato:
- Gamze Nur Teke, medical doctor
- Número de telefone: +905546694389
- E-mail: gamzenur.koca@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Total Post-operative Opioid Consumption
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quality of Recovery-15 (QoR-15) Score
Prazo: 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)
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Incidence of Post-operative Nausea and Vomiting (PONV)
Prazo: 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
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
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Conclusão Primária (Estimado)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
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- 2026/206
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