ESP vs Subcostal TAP Block for Analgesia After Laparoscopic Cholecystectomy (ESP TAP)
Comparison Of Ultrasound-guided Erector Spinae Plane Block And Subcostal Transversus Abdominis Plane Block For Postoperative Analgesia In Laparoscopic Cholecystectomy: A Prospective Randomized Double-blind Multicenter Trial
調査の概要
状態
詳細な説明
Postoperative pain remains a significant clinical concern after laparoscopic cholecystectomy despite the minimally invasive nature of the procedure. Inadequate analgesia may delay recovery, increase opioid consumption, and negatively affect patient satisfaction. Regional anesthesia techniques are increasingly incorporated into multimodal analgesia protocols to improve postoperative outcomes and reduce opioid requirements.
The erector spinae plane (ESP) block and the subcostal transversus abdominis plane (TAP) block are ultrasound-guided fascial plane blocks commonly used for abdominal surgery. While both techniques have demonstrated analgesic benefits, their comparative effectiveness in laparoscopic cholecystectomy remains uncertain. In particular, differences in visceral pain control, opioid-sparing effect, and shoulder pain incidence require further investigation.
This study is designed as a prospective, randomized, double-blind, parallel-group, clinical trial conducted at two tertiary care hospitals in Turkey. Eligible adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomly assigned to receive either bilateral ESP block or bilateral subcostal TAP block after induction of anesthesia. Standardized anesthesia and postoperative multimodal analgesia protocols will be applied in both groups to ensure comparability between centers.
The primary outcome measure is total opioid consumption within the first 24 postoperative hours, expressed as morphine equivalent dose. Secondary outcome measures include postoperative pain scores assessed using the Numerical Rating Scale (NRS), time to first analgesic request, incidence of shoulder pain, postoperative nausea and vomiting, and block-related complications.
Randomization will be performed using a computer-generated sequence, with allocation concealment ensured. Patients and postoperative outcome assessors will be blinded to group assignment. Data will be prospectively recorded and analyzed according to a predefined statistical analysis plan.
The findings of this study are expected to provide evidence-based guidance for optimizing regional analgesia strategies in laparoscopic cholecystectomy.
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：Bekir Suat Kürkçüoğlu
- 電話番号：05055830463
- メール：bekirsuat@gmail.com
研究連絡先のバックアップ
- 名前：Bekir Suat Kürkçüoğlu
- 電話番号：+905055830463
- メール：bekirsuat@gmail.com
研究場所
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Gaziantep
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Şahinbey、Gaziantep、トルコ（Türkiye）、27060
- Gaziantep City Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Adults aged 18 years and older
Scheduled for elective laparoscopic cholecystectomy under general anesthesia
American Society of Anesthesiologists (ASA) physical status I-III
Ability to understand the study protocol and provide written informed consent -
Exclusion Criteria:Refusal to participate
Known allergy or contraindication to local anesthetic agents
Coagulopathy or anticoagulant therapy contraindicating regional anesthesia
Infection at the planned injection site
Body mass index (BMI) > 35 kg/m²
Chronic opioid use or opioid dependence
Chronic pain syndromes requiring regular analgesic treatment
Severe hepatic, renal, or cardiac dysfunction
Pregnancy or breastfeeding
Inability to communicate or assess pain using the Numerical Rating Scale (NRS)
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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 |
|---|---|
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実験的：Erector Spinae Plane Block
Patients in this arm will receive ultrasound-guided bilateral erector spinae plane block following induction of general anesthesia.
A standardized volume and concentration of local anesthetic will be administered at the appropriate thoracic level.
All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia.
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Ultrasound-guided bilateral erector spinae plane block will be performed after induction of general anesthesia.
The block will be administered at the appropriate thoracic vertebral level using a standardized volume and concentration of local anesthetic deposited in the fascial plane deep to the erector spinae muscle.
The procedure will be performed by experienced anesthesiologists under sterile conditions.
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実験的：Subcostal TAP Block
Patients in this arm will receive ultrasound-guided bilateral subcostal transversus abdominis plane block following induction of general anesthesia.
A standardized volume and concentration of local anesthetic will be administered.
All patients will receive standardized intraoperative anesthesia and postoperative multimodal analgesia.
|
Ultrasound-guided bilateral subcostal transversus abdominis plane block will be performed after induction of general anesthesia.
A standardized volume and concentration of local anesthetic will be injected into the fascial plane between the rectus abdominis and transversus abdominis muscles along the subcostal margin.
The procedure will be performed by experienced anesthesiologists under sterile conditions.
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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 |
|---|---|---|
|
Total Opioid Consumption in the First 24 Hours Postoperatively
時間枠：Within 24 hours after surgery
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Total opioid consumption during the first 24 postoperative hours, converted to intravenous morphine equivalent dose (mg), recorded from patient-controlled analgesia devices and supplemental opioid administration.
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Within 24 hours after surgery
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Bekir Suat Kurkcuoglu、Gaziantep City Hospital
出版物と役立つリンク
一般刊行物
- This study will generate individual participant data (IPD) related to postoperative analgesia, including opioid consumption, pain scores, and block-related complications. Data will be de-identified prior to sharing. Access to IPD will be available upon reasonable request to the corresponding author after publication of the main study results. Data requests will require a signed data use agreement, specifying the purpose of analysis and acknowledgment of original investigators. Supporting documentation, including study protocol and statistical analysis plan, will also be provided to researchers granted access.
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
その他の研究ID番号
- BS-ESP-TAP-2026
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?
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。