Serratus Posterior Superior Intercostal Plane Block in Port Catheter Implantation
Comparison of Serratus Posterior Superior Intercostal Plane Block and Local Infiltration for Analgesia During Port Catheter Implantation: A Prospective Randomized Study
調査の概要
状態
詳細な説明
This prospective, randomized controlled study evaluates the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block compared with standard local anesthetic infiltration in patients undergoing port catheter implantation. Although the procedure is usually performed under local anesthesia, patients may experience significant pain during port pocket creation.
Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided SPSIP block or local anesthetic infiltration. All patients will receive standardized monitoring and premedication. Pain intensity during different procedural stages, postoperative pain scores, analgesic consumption, and satisfaction levels will be assessed.
The study aims to determine whether SPSIP block improves intraoperative analgesia and reduces analgesic requirements compared to local infiltration.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Outside of the US
-
Diyarbakır、Outside of the US、トルコ（Türkiye）、21070
- Fatma Acil
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-
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:
- Age 18-75 years
- ASA physical status I-III
- Scheduled for elective port catheter implantation
- Ability to understand and use the Numeric Rating Scale (NRS)
- Provided written informed consent
Exclusion Criteria:
- Known allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or anticoagulant therapy
- Severe pulmonary disease
- G6PD deficiency
- Pregnancy or breastfeeding
- Inability to assess pain or communicate effectively
- Refusal to participate
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
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：Local Infiltration
Participants will receive standard local anesthetic infiltration during port catheter implantation.
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Standard local anesthetic infiltration performed at the surgical site during port catheter implantation.
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実験的：Serratus Posterior Superior Intercostal Plane Block
Participants will receive an ultrasound-guided SPSIP block prior to port catheter implantation.
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Ultrasound-guided Serratus Posterior Superior Intercostal plane block performed prior to the procedure.
他の名前：
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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 |
|---|---|---|
|
Pain intensity during port pocket creation
時間枠：During procedure
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Pain intensity during port pocket creation measured using the Numeric Rating Scale (0-10), where higher scores indicate greater pain. Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. |
During procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum intraoperative pain score
時間枠：During the procedure
|
The highest pain intensity recorded during any procedural stage will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
During the procedure
|
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Pain intensity during procedural stages
時間枠：During the procedure
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Pain intensity will be assessed during skin puncture, catheter tunneling, and skin closure using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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During the procedure
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Total supplemental local anesthetic amount
時間枠：During the procedure
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Total amount of additional local anesthetic administered during the procedure will be recorded in milliliters.
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During the procedure
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Postoperative pain scores
時間枠：0, 2, 6, 12, and 24 hours after the procedure
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Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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0, 2, 6, 12, and 24 hours after the procedure
|
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Total tramadol consumption
時間枠：Within 24 hours after the procedure
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Total intravenous tramadol consumption within the first 24 hours after the procedure will be recorded in milligrams.
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Within 24 hours after the procedure
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Duration of effective analgesia
時間枠：Within 24 hours after the procedure
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Duration of effective analgesia will be defined as the time interval from completion of the procedure to the first administration of rescue analgesia.
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Within 24 hours after the procedure
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Patient satisfaction score
時間枠：After the procedure
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Patient satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
Higher scores indicate greater satisfaction.
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After the procedure
|
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Surgeon satisfaction score
時間枠：After the procedure
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Surgeon satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
Higher scores indicate greater satisfaction.
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After the procedure
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Procedure-related complications
時間枠：During and within 24 hours after the procedure
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Procedure-related complications, including pneumothorax, hematoma, local anesthetic systemic toxicity, methemoglobinemia, and infection, will be recorded.
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During and within 24 hours after the procedure
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協力者と研究者
捜査官
- 主任研究者：Fatma Acil, M.D.、Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
その他の研究ID番号
- 07/04/2026-123
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