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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Gamze Nur Teke, medical doctor
- 电话号码:+905546694389
- 邮箱:gamzenur.koca@gmail.com
学习地点
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şahinbey
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Gaziantep、şahinbey、土耳其(türkiye)、27072
- Gaziantep City Hospital
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接触:
- Gamze Nur Teke, medical doctor
- 电话号码:+905546694389
- 邮箱:gamzenur.koca@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total Post-operative Opioid Consumption
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Recovery-15 (QoR-15) Score
大体时间: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)
大体时间: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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Post-operative Nausea and Vomiting (PONV)
大体时间: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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合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2026/206
计划个人参与者数据 (IPD)
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IPD 计划说明
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