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Subcostal Transversus Abdominis Plane Block

2026年5月17日 更新者:Atakan Ozkan、Esencan Hospital

Is the Application of Subcostal Transversus Abdominis Plane Block Effective for Pain Control in Classical Four-Port Laparoscopic Cholecystectomy?

This non-randomized controlled study evaluated the efficacy of a right-sided unilateral Transversus Abdominis Plane (TAP) block for postoperative pain management in 60 adult patients undergoing elective laparoscopic cholecystectomy. Participants were equally divided into a control group receiving standard care and an intervention group that received an ultrasound-guided TAP block using 0.25% bupivacaine prior to extubation. While all patients received scheduled paracetamol and dexketoprofen, tramadol was administered as a rescue analgesic for resting pain scores of 5 or higher. The study's primary goal was to compare postoperative pain using the Verbal Numerical Rating Scale (VNRS) at 0, 6, 12, and 24 hours, with secondary outcomes tracking total rescue tramadol consumption, surgical variables, and postoperative complications to determine the TAP block's overall clinical benefit.

調査の概要

状態

完了

介入・治療

詳細な説明

This non-randomised controlled study was conducted from May 2023 to July 2023 after receiving approval from the Institutional Ethical Review Board. The study protocol adhered to the ethical guidelines of the Declaration of Helsinki. Prior to surgery, written informed consent was obtained from all participants. The inclusion criteria for this study were as follows: individuals aged 18 years or older, scheduled for elective laparoscopic cholecystectomy to treat cholelithiasis, American Society of Anesthesiologists (ASA) physical status of I or II, with no communication barriers, able to cooperate during the intervention, and understanding the use of relevant assessment scales. The exclusion criteria encompassed the following: individuals with contraindications to nerve block, such as infection at the puncture site; those diagnosed with malignancy; individuals suffering from severe liver and kidney diseases, coagulation dysfunction, or similar conditions; individuals with a history of previous abdominal surgery or trauma; long-term users of sedative and analgesic drugs, or those with addiction to alcohol, sedatives, or analgesics; individuals experiencing chronic pain; those with known allergies to the drugs used in the study; individuals with mental illnesses that interfere with perception and pain assessment; individuals taking analgesics prior to surgery; individuals with a body mass index (BMI) ≥ 35; patients who were converted from laparoscopic surgery to open surgery; perforation of the gallbladder during cholecystectomy; women who are pregnant or breastfeeding, and patients who withdrew their consent at any stage of the study.

According to the results of the study performed by Ozciftci et al. (13) and using the the calculator at https://www.istatistikakademisi.com/sayfa/nicel-verilerde-orneklem-buyuklugu-hesabi.html, the standard effect size was determined as 0.78 with a 5% margin of error and 80% power, and it was deemed sufficient to include n = 26 cases in each group, and for this reason, 30 patients in each group, a total of 60 patients, were included in the study. The patients were equally divided into two groups in order to their administration to the hospital one by one. The control group (Group 1, n=30) consisted of patients who did not receive a TAP block, while Group 2 (n=30) comprised patients who underwent a right-sided unilateral TAP block. One patient who had malignant gallbladder pathology after LC and fou patients who gave missing data or who didn't want to participate in the study excluded during the study and five new patients enrolled.

Throughout the procedure, the study adhered to the established institutional protocol for anesthesia induction, monitoring, and maintenance. All patients underwent a standardized anesthesia induction process (using 2-3 mg/kg of propofol, 0.6-1.2 mg/kg of rocuronium, and 1 μg/kg of fentanyl). Following orotracheal intubation, patients were adjusted to maintain a tidal volume of 8 mL/kg, an Inspiration: Expiration ratio of 1:2, a respiratory rate of 12/min, and an end tidal CO2 level ranging from 30 to 40 mmHg in controlled ventilation mode. Anesthesia Throughout the procedure, the study adhered to the established institutional protocol for anesthesia induction, monitoring, and maintenance. All patients underwent a standardized anesthesia induction process (using 2-3 mg/kg of propofol, 0.6-1.2 mg/kg of rocuronium, and 1 μg/kg of fentanyl). Following orotracheal intubation, patients were adjusted to maintain a tidal volume of 8 mL/kg, an Inspiration: Expiration ratio of 1:2, a respiratory rate of 12/min, and an end-tidal CO2 level ranging from 30 to 40 mmHg in controlled ventilation mode. Anesthesia maintenance was achieved through a mixture of 60% oxygen and 40% air, along with sevoflurane (maintaining a minimum alveolar concentration of 2.5-3.0).

All surgical procedures were performed by two experienced senior surgeons. The surgeries followed a consistent approach. A 10mm incision was made in the midline, 2 cm below the xiphoid, and a 10mm periumbilical incision was made parallel to the pelvis. Two additional 5mm right subcostal incisions were performed for trocar insertion during laparoscopic cholecystectomy. All surgical procedures were conducted using a laparoscopic approach, and the abdomen was insufflated with CO2, with the insufflation pressure limited to 13 mmHg throughout the procedure. If a drain was used during the surgery, it was taken out of the abdomen through the 5mm trocar.

The TAP block was performed during the post-anesthesia phase before extubation. The procedure involved the use of an ultrasound system and a linear ultrasound transducer (6-12 Hz). To perform the TAP block, the linear probe was positioned 2 cm below the xiphoid to locate the rectus abdominis muscle and fascia. Moving the probe in a downward and lateral direction, the external oblique, internal oblique, and transversus abdominis muscles and fascia were identified over the oblique subcostal angle. A 1-2 ml dose of 2% lidocaine was then applied at the insertion site of the peripheral block needle. With the probe in the oblique subcostal position, the peripheral block needle (Braun, Ultra360, 100 mm, Germany) was carefully advanced along the fascia of the transversus abdominis and internal oblique muscles, from the medial to the inferolateral area of the probe. The accuracy of the block area was confirmed by infiltrating 1-2 ml of 0.9% isotonic sodium chloride, resulting in a hypoechoic and biconvex appearance, as described in the research conducted by Lee et al. (14), and 20 ml of 0.25% bupivacaine on the right side of the abdomen, following the administration described in Sahin et al.'s study (15).

Intravenous infusion of Paracetamol 1 g (Perfalgan®, Bristol-Myers Squibb, USA) was given to all patients at three time points: immediately after surgery, at the 6th hour, and at the 18th hour after surgery. Additionally, all patients received routine intravenous administration of dexketoprofen 50 mg (Arveles®, Menarini, Italy), immediately after surgery and at the 12th hour after surgery to manage pain. Verbal Numerical Rating Scale (VNRS) was administered to all volunteers for pain assessment as primary outcome at postoperative 0, 6, 12, and 24 hours, where scores between 0 and 10 could be assigned. If a patient reported a VNRS score of 5 or higher while at rest, they were given Tramadol hydrochloride (Contramal®, Grünenthal, Germany) at a dose of 0.5 mg/kg. The total amount of tramadol consumed after surgery, as well as age, gender, BMI, operation time, the use of a drain, and postoperative complications, were recorded for each patient as scondary outcome.

研究の種類

介入

入学 (実際)

60

段階

  • 適用できない

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。

研究場所

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

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

いいえ

調査対象母集団

Patients who have cholelithiasis

説明

Inclusion Criteria:

  • individuals aged 18 years or older, scheduled for elective laparoscopic cholecystectomy to treat cholelithiasis, American Society of Anesthesiologists (ASA) physical status of I or II, with no communication barriers, able to cooperate during the intervention, and understanding the use of relevant assessment scales

Exclusion Criteria:

  • individuals with contraindications to nerve block, such as infection at the puncture site; those diagnosed with malignancy; individuals suffering from severe liver and kidney diseases, coagulation dysfunction, or similar conditions; individuals with a history of previous abdominal surgery or trauma; long-term users of sedative and analgesic drugs, or those with addiction to alcohol, sedatives, or analgesics; individuals experiencing chronic pain; those with known allergies to the drugs used in the study; individuals with mental illnesses that interfere with perception and pain assessment; individuals taking analgesics prior to surgery; individuals with a body mass index (BMI) ≥ 35; patients who were converted from laparoscopic surgery to open surgery; perforation of the gallbladder during cholecystectomy; women who are pregnant or breastfeeding, and patients who withdrew their consent at any stage of the study.

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

  • 主な目的:防止
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • 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
他の:TAP Block Group
Patients with TAP block
The TAP block was performed during the post-anesthesia phase before extubation. The procedure involved the use of an ultrasound system and a linear ultrasound transducer. To perform the TAP block, the linear probe was positioned 2 cm below the xiphoid to locate the rectus abdominis muscle and fascia. Moving the probe in a downward and lateral direction, the external oblique, internal oblique, and transversus abdominis muscles and fascia were identified over the oblique subcostal angle. A 1-2 ml dose of 2% lidocaine was then applied at the insertion site of the peripheral block needle. With the probe in the oblique subcostal position, the peripheral block needle was carefully advanced along the fascia of the transversus abdominis and internal oblique muscles, from the medial to the inferolateral area of the probe.
介入なし:Control Group
Patients without TAP block

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 scale measurements
時間枠:24 hours
Verbal Numerical Rating Scale (from 0-10) for pain
24 hours

協力者と研究者

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出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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)

2023年5月15日

一次修了 (実際)

2023年7月15日

研究の完了 (実際)

2023年8月15日

試験登録日

最初に提出

2026年5月1日

QC基準を満たした最初の提出物

2026年5月1日

最初の投稿 (実際)

2026年5月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月20日

QC基準を満たした最後の更新が送信されました

2026年5月17日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • TAP Block

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?

未定

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

いいえ

米国FDA規制機器製品の研究

いいえ

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