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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Gamze Nur Teke, medical doctor
- 電話番号：+905546694389
- メール：gamzenur.koca@gmail.com
研究場所
-
-
şahinbey
-
Gaziantep、şahinbey、トルコ（Türkiye）、27072
- Gaziantep City Hospital
-
コンタクト：
- Gamze Nur Teke, medical doctor
- 電話番号：+905546694389
- メール：gamzenur.koca@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Post-operative Opioid Consumption
時間枠：Up to 24 hours post-operatively.
|
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.
|
Up to 24 hours post-operatively.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Recovery-15 (QoR-15) Score
時間枠：Baseline (pre-operatively) and at 24 hours post-operatively.
|
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.
|
Baseline (pre-operatively) and at 24 hours post-operatively.
|
|
Post-operative Pain Intensity (NRS Scores)
時間枠：At post-operative 1st, 2nd, 4th, 6th, 12th, and 24th hours.
|
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).
|
At post-operative 1st, 2nd, 4th, 6th, 12th, and 24th hours.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Post-operative Nausea and Vomiting (PONV)
時間枠：Up to 24 hours post-operatively.
|
The presence or absence of nausea, vomiting, or the need for antiemetic medication will be monitored and recorded as a percentage or scale score.
|
Up to 24 hours post-operatively.
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2026/206
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。