ESP Block vs. EXORA Block for Postoperative Pain in Nephrectomy
Prospective Comparison of Postoperative Analgesic Effects of ESP Block and EXORA Block in Nephrectomy Cases
The goal of this observational study is to learn about the effects of two pain control techniques used after laparoscopic nephrectomy (kidney removal surgery) in adults. The study will compare Erector Spinae Plane (ESP) block and External Oblique Rectus Abdominis (EXORA) block, which are both used as part of routine medical care to help control pain after surgery.
The main questions it aims to answer are:
Do ESP block and EXORA block differ in how well they control pain after surgery? Do ESP block and EXORA block differ in their effects on recovery quality and the need for additional pain medication?
Researchers will compare participants who receive ESP block with participants who receive EXORA block as part of routine clinical care.
Participants will:
Undergo laparoscopic nephrectomy according to routine clinical practice. Receive either ESP block or EXORA block based on the treating anesthesiologist's usual clinical preference.
Complete a recovery questionnaire before surgery and 24 hours after surgery. Have pain scores, use of additional pain medication, nausea and vomiting, and other routine postoperative measurements recorded during the first 24 hours after surgery.
調査の概要
詳細な説明
In routine practice at our institution, anesthesia clinicians performing laparoscopic nephrectomy administer either an Erector Spinae Plane (ESP) block or an External Oblique Rectus Abdominis (EXORA) block based solely on individual clinician preference. The researcher does not influence this decision. Among the eligible patients, those receiving either ESP or EXORA block will be included and evaluated observationally. Block types other than these two will not be included.
All postoperative visits and clinical follow-ups are routinely conducted by the hospital's pain management team. The researcher does not intervene in these clinical processes and is only responsible for obtaining informed consent, recording demographic variables, documenting the type of block performed, and administering the QoR-15 questionnaire preoperatively and at postoperative 24 hours.
Preoperative evaluation and necessary laboratory testing are carried out according to standard hospital practice by the attending anesthesiologist. In the operating room, standard monitoring (non-invasive blood pressure, ECG, heart rate, and oxygen saturation) is applied. Anesthesia induction is performed using standard agents and general anesthesia is maintained according to the clinician's routine practice.
For postoperative analgesia, all patients routinely receive intravenous paracetamol 1 g every 8 hours. Rescue analgesia consists of intravenous tramadol 1 mg/kg when NRS ≥4. After surgery, patients are monitored in the PACU and transferred to the ward once their Aldrete score is ≥9.
Postoperative nausea and vomiting (PONV) are assessed using a verbal descriptive scale (0-4) and intravenous ondansetron 4 mg is administered for PONV ≥2.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Şeyma Nur Güner Zengin, MD
- 電話番号：+90 212 414 71 71
- メール：snurguner@gmail.com
研究連絡先のバックアップ
- 名前：Nalan Saygı Emir, MD, Associate Professor
- 電話番号：+90 212 414 71 71
- メール：nasaemir@hotmail.com
研究場所
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Istanbul
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Istanbul、Istanbul、トルコ（Türkiye）、34147
- 募集
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age between 18 and 80 years
- Patients scheduled for laparoscopic nephrectomy
- Patients for whom Erector Spinae Plane (ESP) block or External Oblique Rectus Abdominis (EXORA) block has been selected by the treating clinician
- ASA physical status I-III
Exclusion Criteria:
- No regional block performed in routine clinical practice
- Body mass index (BMI) greater than 35 kg/m²
- History of opioid dependence
- Alcohol or other substance dependence
- Psychiatric disease, mental retardation, dementia, or any condition impairing pain perception or pain assessment
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Group E
Participants undergoing laparoscopic nephrectomy who receive Erector Spinae Plane (ESP) block as part of routine clinical care.
|
An ultrasound-guided Erector Spinae Plane (ESP) block is performed under general anesthesia prior to extubation as part of routine clinical practice.
After aseptic preparation, a linear ultrasound probe is placed over the T10 transverse process on the surgical side.
The needle is advanced into the fascial plane between the erector spinae muscle and the transverse process.
Following negative aspiration and confirmation of correct needle placement with hydrodissection, 30 mL of 0.25% bupivacaine is injected.
The procedure is performed by anesthesiologists according to routine clinical practice without researcher involvement in clinical decision-making.
他の名前：
|
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Group X
Participants undergoing laparoscopic nephrectomy who receive External Oblique Rectus Abdominis (EXORA) block as part of routine clinical care.
|
An ultrasound-guided External Oblique Rectus Abdominis (EXORA) block is performed under general anesthesia prior to extubation as part of routine clinical practice.
After aseptic preparation, a linear ultrasound probe is positioned in the parasternal sagittal plane lateral to the xiphoid process at the level of the 8th costal cartilage on the surgical side.
The needle is advanced into the fascial plane between the rectus abdominis and external oblique muscles.
Following negative aspiration and confirmation of correct needle placement with hydrodissection, 30 mL of 0.25% bupivacaine is injected.
The procedure is performed by anesthesiologists according to routine clinical practice without researcher involvement in clinical decision-making.
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
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Pain Score (NRS)
時間枠：Postoperative 1, 6, 12, and 24 hours
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Postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10).
Pain scores will be recorded at 1, 6, 12, and 24 hours after surgery and will be compared between Group E and Group X.
The Numeric Rating Scale ranges from 0 to 10 (0 = no pain, 10 = worst imaginable pain); higher scores indicate worse pain.
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Postoperative 1, 6, 12, and 24 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rescue Analgesic Requirement
時間枠：First 24 hours after surgery
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The requirement for rescue analgesia and the total amount of postoperative tramadol consumption during the first 24 hours will be recorded and compared between Group E and Group X.
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First 24 hours after surgery
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Quality of Recovery (QoR-15 Score)
時間枠：Preoperative baseline and postoperative 24th hour
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Quality of recovery will be assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire.
Scores will be compared between Group E and Group X.
The QoR-15 total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
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Preoperative baseline and postoperative 24th hour
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative Nausea and Vomiting (PONV) Score
時間枠：Postoperative 1, 6, 12, and 24 hours
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Postoperative nausea and vomiting will be assessed using a verbal descriptive scale from 0 to 4 (0 = none, 1 = mild, 2 = moderate, 3 = single vomiting episode, 4 = multiple vomiting episodes).
Scores will be compared between Group E and Group X.
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Postoperative 1, 6, 12, and 24 hours
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
- Okmen K, Demirel A, Dogan AK, Ertus CY. Application of EXORA block for analgesia following hand-assisted laparoscopic donor nephrectomy (HALDN). Indian J Anaesth. 2025 Mar;69(3):324-326. doi: 10.4103/ija.ija_1263_24. Epub 2025 Feb 17. No abstract available.
- Nalbant B, Donmez A, Altinsoy S, Kavak Akelma F. Efficacy of OSTAP, ESP block, trocar site local anesthetic injection in elective laparoscopic cholecystectomy: A randomized controlled trial. Medicine (Baltimore). 2025 Aug 1;104(31):e43607. doi: 10.1097/MD.0000000000043607.
- Yang M, Cao L, Lu T, Xiao C, Wu Z, Jiang X, Wang W, Li H. Ultrasound-guided erector spinae plane block for perioperative analgesia in patients undergoing laparoscopic nephrectomies surgery: a randomized controlled trial. Trials. 2024 Jan 2;25(1):10. doi: 10.1186/s13063-023-07866-0.
- Amir S, Siddiqui AH, Haris M, Laique F, Amini B, Mehboob M, Mohiuddin M, Azam MM, Mukhtar S, Akram Z, Zainab B, Rizwan S, Moeed A, Surani S. Ultrasound-guided erector spinae plane block for perioperative analgesia in laparoscopic nephrectomy: A systematic review and meta-analysis. World J Nephrol. 2025 Dec 25;14(4):110268. doi: 10.5527/wjn.v14.i4.110268.
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
- BEAH 2026/191
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。
術後の痛みの臨床試験
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Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
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Dexa Medica Group完了
Erector Spinae Plane Blockの臨床試験
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Ankara University完了術後せん妄 | 術後疼痛管理 | 胸骨切開トルコ（Türkiye）
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Erzurum Regional Training & Research Hospital完了
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Chinese PLA General Hospitalまだ募集していません痛み、術後 | 局所麻酔 | 腹横筋面ブロック（TAPブロック）
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London Health Sciences Centre Research Institute...募集