SPSIPB Versus SAPB for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum
2026年7月6日 更新者：Ulgen Zengin、Marmara University
Comparison of the Postoperative Analgesic Effects of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block After Minimally Invasive Repair of Pectus Excavatum: A Prospective Observational Cohort Study
This prospective observational cohort study will compare postoperative analgesic outcomes in patients undergoing minimally invasive repair of pectus excavatum.
Participants will be grouped according to the regional analgesia technique applied as part of routine clinical care: serratus posterior superior intercostal plane block or serratus anterior plane block.
The primary outcome will be total opioid consumption during the first 24 hours after surgery.
Secondary outcomes will include postoperative pain scores, rescue analgesic requirement, opioid-related adverse effects, patient satisfaction, mobilization time, and length of hospital stay.
調査の概要
状態
状態
募集
条件
条件
介入・治療
介入・治療
詳細な説明
Pectus excavatum is the most common chest wall deformity in pediatric and adolescent patients and is characterized by posterior depression of the sternum and anterior chest wall. Although many patients are asymptomatic, corrective surgery is frequently performed during adolescence or young adulthood for cosmetic reasons and to improve body image and quality of life.
Minimally invasive repair of pectus excavatum involves the placement of a curved metal bar beneath the sternum. The bar is then rotated to elevate the sternum and correct the chest wall deformity. Despite favorable cosmetic and quality-of-life outcomes, postoperative pain remains a major clinical challenge after this procedure. Pain is mainly related to sternal elevation, pressure exerted by the bar, and repositioning of the ribs. Inadequate pain control may increase opioid consumption and prolong hospitalization. Higher opioid exposure may also lead to adverse effects such as nausea, vomiting, constipation, pruritus, and urinary retention.
Regional anesthesia techniques have become important components of multimodal postoperative analgesia in thoracic surgery. Thoracic paravertebral block, erector spinae plane block, and serratus anterior plane block are among the regional techniques commonly used for thoracic analgesia. Serratus anterior plane block has also been used for postoperative pain management after minimally invasive repair of pectus excavatum.
Serratus posterior superior intercostal plane block is a recently described ultrasound-guided interfascial plane block. The technique involves injection of local anesthetic between the serratus posterior superior muscle and the rib, usually at the level of the second or third rib. This block has been reported to provide analgesia in various thoracic and scapular pain conditions and has shown promising results in thoracic surgery.
The aim of this study is to compare the postoperative analgesic outcomes of serratus posterior superior intercostal plane block and serratus anterior plane block in patients undergoing minimally invasive repair of pectus excavatum. Because this is an observational study, the choice of regional analgesia technique will not be determined by the study protocol. The block technique will be selected by the attending anesthesiologist according to routine clinical practice. No randomization or protocol-driven assignment will be performed.
研究の種類
研究の種類
観察的
入学 (推定)
入学
80
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Cem Özdemir, MD
- 電話番号：+905385027687
- メール：suskungeveze.cem@gmail.com
研究連絡先のバックアップ
- 名前：Seniyye Ülgen Zengin, Associate Professor, MD
- 電話番号：+905057142443
- メール：ulgen_t@yahoo.com
研究場所
-
-
Istanbul
-
Istanbul、Istanbul、トルコ（Türkiye）、34722
- 募集
- Marmara University
-
コンタクト：
- Cem Özdemir, MD
- 電話番号：+905385027687
- メール：suskungeveze.cem@gmail.com
-
コンタクト：
- Seniyye Ülgen Zengin, Associate Professor, MD
- 電話番号：+905057142443
- メール：ulgen_t@yahoo.com
-
主任研究者：
- Seniyye Ülgen Zengin, Associate Professor, MD
-
副調査官：
- Cem Özdemir, MD
-
副調査官：
- Meliha Orhon Ergün, Associate Professor, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
The study population will include patients aged 15 to 25 years who are diagnosed with pectus excavatum and scheduled to undergo minimally invasive repair of pectus excavatum under general anesthesia.
Patients who receive either bilateral serratus posterior superior intercostal plane block or bilateral serratus anterior plane block as part of routine perioperative analgesic care will be included.
説明
Inclusion Criteria:
- Patients aged 15 to 25 years
- Diagnosis of pectus excavatum
- Scheduled to undergo minimally invasive repair of pectus excavatum under general anesthesia
- Receipt of either bilateral serratus posterior superior intercostal plane block or bilateral serratus anterior plane block as part of routine perioperative analgesic care
- Written informed consent obtained from the patient or, for patients younger than 18 years, from a legal guardian
Exclusion Criteria:
- Refusal to participate in the study
- Contraindication to regional anesthesia
- Known allergy to local anesthetics or study analgesic medications
- Chronic opioid use
- Pre-existing chronic pain syndrome
- Coagulopathy or use of anticoagulant therapy that contraindicates regional block application
- Local infection at the block injection site
- Neurological or psychiatric condition that may interfere with pain assessment
- Incomplete perioperative or postoperative data
- Conversion to another surgical technique or major intraoperative complication requiring a change in the routine analgesic protocol
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
グループ/コホートの数
2
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
Serratus Anterior Plane Block Group
Participants in this cohort will receive bilateral ultrasound-guided serratus anterior plane block as part of routine perioperative analgesic care.
|
Bispectral Index（BIS）デバイスを用いた持続的術中麻酔深度モニタリング。
BIS値は、麻酔薬の滴定を支援し、研究コホート間で麻酔深度を標準化するために、手技全体を通じて記録されます。
BISデバイスはモニタリングのみに使用され、デバイス関連の研究手順は実施されません。
他の名前：
All participants will receive a standardized multimodal postoperative analgesia protocol.
Patient-controlled analgesia with intravenous morphine will be used.
The device will be programmed to administer 1 mg of intravenous morphine per demand, with a lockout interval of 10 minutes.
Paracetamol will be administered as part of routine multimodal analgesia.
If adequate analgesia cannot be achieved, 100 mg tramadol will be administered as rescue analgesia according to clinical need.
Bilateral ultrasound-guided serratus anterior plane block will be performed according to standard techniques described in the literature and routinely used in the clinic.
Local anesthetic dosing will be determined according to institutional practice and safety limits.
In bilateral applications, the total bupivacaine dose will not exceed 2.5 mg/kg.
他の名前：
|
|
Serratus Posterior Superior Intercostal Plane Block Group
Participants in this cohort will receive bilateral ultrasound-guided serratus posterior superior intercostal plane block as part of routine perioperative analgesic care.
|
Bispectral Index（BIS）デバイスを用いた持続的術中麻酔深度モニタリング。
BIS値は、麻酔薬の滴定を支援し、研究コホート間で麻酔深度を標準化するために、手技全体を通じて記録されます。
BISデバイスはモニタリングのみに使用され、デバイス関連の研究手順は実施されません。
他の名前：
All participants will receive a standardized multimodal postoperative analgesia protocol.
Patient-controlled analgesia with intravenous morphine will be used.
The device will be programmed to administer 1 mg of intravenous morphine per demand, with a lockout interval of 10 minutes.
Paracetamol will be administered as part of routine multimodal analgesia.
If adequate analgesia cannot be achieved, 100 mg tramadol will be administered as rescue analgesia according to clinical need.
Bilateral ultrasound-guided serratus posterior superior intercostal plane block will be performed according to standard techniques described in the literature and routinely used in the clinic.
Local anesthetic dosing will be determined according to institutional practice and safety limits.
In bilateral applications, the total bupivacaine dose will not exceed 2.5 mg/kg.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total postoperative opioid consumption during the first 24 hours
時間枠：From the end of surgery to 24 hours postoperatively
|
Total opioid consumption during the first 24 hours after surgery will be recorded and expressed as intravenous morphine equivalents in milligrams.
|
From the end of surgery to 24 hours postoperatively
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intraoperative opioid consumption
時間枠：From induction of anesthesia to the end of surgery
|
Total intraoperative opioid consumption will be recorded.
|
From induction of anesthesia to the end of surgery
|
|
Postoperative pain scores
時間枠：At arrival in the post-anesthesia care unit and at postoperative 6, 12, 24, and 48 hours
|
Pain intensity will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
|
At arrival in the post-anesthesia care unit and at postoperative 6, 12, 24, and 48 hours
|
|
Patient satisfaction
時間枠：At postoperative 6, 12, 24, and 48 hours
|
Patient satisfaction with postoperative analgesia will be assessed using a 4-point Likert scale, where 0 indicates very dissatisfied and 3 indicates very satisfied.
|
At postoperative 6, 12, 24, and 48 hours
|
|
Incidence of Opioid-Related Adverse Effects
時間枠：From the end of surgery to 48 hours postoperatively
|
Presence of nausea, vomiting, pruritus, constipation, urinary retention, sedation, and respiratory depression.
Adverse effects will be compared among the two groups.
|
From the end of surgery to 48 hours postoperatively
|
|
Duration of anesthesia
時間枠：Intraoperative period
|
The total duration of anesthesia will be recorded in minutes.
|
Intraoperative period
|
|
Duration of surgery
時間枠：Intraoperative period
|
The total duration of surgery will be recorded in minutes.
|
Intraoperative period
|
|
Time to mobilization
時間枠：From the end of surgery until the first documented ambulation, assessed within the first 48 postoperative hours
|
The time from the end of surgery to first mobilization will be recorded.
|
From the end of surgery until the first documented ambulation, assessed within the first 48 postoperative hours
|
|
Length of hospital stay
時間枠：Length of postoperative hospital stay, defined as the time from the end of surgery to hospital discharge, assessed up to 30 days postoperatively
|
The duration of postoperative hospitalization will be recorded.
|
Length of postoperative hospital stay, defined as the time from the end of surgery to hospital discharge, assessed up to 30 days postoperatively
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
捜査官
- スタディチェア：Cem Özdemir, MD、Marmara University
- 主任研究者：Seniyye Ülgen Zengin, Associate Professor, MD、Marmara University
- スタディディレクター：Meliha Orhon Ergün, Associate Professor, MD、Marmara University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
研究開始
2026年6月22日
一次修了 (推定)
一次修了
2027年6月1日
研究の完了 (推定)
研究の完了
2027年6月1日
試験登録日
最初に提出
最初に提出
2026年6月30日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年7月6日
最初の投稿 (実際)
最初の投稿
2026年7月13日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年7月13日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年7月6日
最終確認日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 09.2026.769
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?
いいえ
IPD プランの説明
Individual participant data (IPD) will not be shared.
The study involves clinical information collected under institutional ethical approval, and no consent was obtained for external sharing of identifiable or de-identified participant-level data.
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
はい
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
はい
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。