Intertransverse Process Block Versus M-TAPA Block After Laparoscopic Hysterectomy
2026年5月15日 更新者:Beste Mutlu Dağlıoğlu、Antalya City Hospital
Intertransverse Process Block Versus M-TAPA Block After Laparoscopic Hysterectomy: A Prospective Randomized Controlled Trial
This randomized clinical trial aims to evaluate and compare the analgesicefficacy of the Intertransverse Process Block (ITPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) in patients undergoing laparoscopic hysterectomy.
The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hours after surgery.
Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block- related complications and adverse effects (hematoma, pneumothorax, local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.
調査の概要
状態
まだ募集していません
詳細な説明
Study Objective: This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management.
The primary objective is to compare the effects of Intertransverse Process Block (ITPB) and M-TAPA Block on Visual Analog Scale (VAS) scores in patients undergoing laparoscopic hysterectomy.
Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours, requirement for rescue analgesia, block-related and systemic complications (hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.Materials and Methods: This prospective, randomized clinical study will include voluntary patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) 18-35 kg/m².
All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion.
Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain.
Patients who meet the exclusion criteria will be withdrawn from the study.
Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org).
Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.Study Groups and Block Procedures: Group ITP will receive a bilateral ITP block, and Group M-TAPA will receive a bilateral M-TAPA block.
All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO2), and non-invasive blood pressure prior to the block.
Premedication with intravenous midazolam (0.02 mg/kg) will be administered.ITP Block :Intertransverse Process Block (ITP) will be performed 30 minutes prior to surgery with the patient in a sitting position.
After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey).
A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned along the medial border of spinous processes level of the T10 thoracic vertebrae.Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T10 level, will be identified.
Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes.
Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating separation within the intertransverse plane.
Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.M-TAPA Block:The Block will be performed 30 minutes prior to surgery with the patient in a supine position.
After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey).
A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned obliquely along the costal margin at the level of the 10th costal cartilage.Anatomical landmarks, including the costal cartilage, rectus abdominis muscle, transversus abdominis muscle, and internal oblique muscle will be identified.
Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted toward the perichondrial plane beneath the 10th costal cartilage under ultrasound guidance.
Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline.
Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.General Anesthesia Upon entry into the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure.
Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide (0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey).
Anesthesia maintenance will be provided using 6% desflurane in a 40%oxygen-air mixture and a continuous remifentanil infusion at 0.05 mcg/kg/min.
Mechanical ventilation settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO# maintained at 30-35 mmHg.
Anesthetic depth will be monitored continuously using a Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value of 40-60.
If heart rate or mean arterial pressure increases >20% from baseline, the remifentanil dose will be titrated accordingly.Thirty minutes before the end of surgery, all patients will receive 15 mg/kg of intravenous paracetamol (e.g., Paracerol®, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey) and 1 mg/kg of intravenous tramadol.
To prevent nausea and vomiting, 4 mg intravenous ondansetron will be administered.
Patients with adequate spontaneous ventilation will be extubated and transferred to the post-anesthesia care unit (PACU).
Hemodynamic Monitoring Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded at the following time points: pre-induction (baseline), 5 minutes after induction, 5 minutes after surgical incision, 15 minutes after incision, and at the end of surgery.Postoperative Pain and Analgesic Use: Pain will be assessed using the VAS at rest (static) and during movement (dynamic) at 0, 1, 4, 8, 12, and 24 hours postoperatively.All patients will use patient-controlled analgesia (PCA) without a basal infusion.
The PCA device will be set to deliver 1 mg of morphine (0.2 mg/mL concentration) with a 10-minute lockout interval.
Patients will be instructed to press the PCA button when VAS ≥4.
Intravenous paracetamol will be administered every 8 hours.
Rescue analgesia with intravenous tramadol (1 mg/kg) will be provided if VAS scores remain ≥4.
The total amounts of opioids, NSAIDs, and other analgesics will be recorded.Postoperative Recovery Quality Postoperative recovery will be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire, which evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state.Patient Satisfaction Satisfaction will be evaluated using a 5-pointLikert scale, where 1 = not satisfied and 5 = very satisfied, based on verbalfeedback from both the patient and the surgeon.Nausea and Vomiting: Nausea and vomiting will be scored using a 4-point scale:0 = none1.
= mild2.
= moderate3.
= severe Potential Complications Any complications associated withthe block or the surgical procedure (e.g., hematoma, pneumothorax,local anesthetic systemic toxicity, vascular puncture, or infection) will berecorded.
研究の種類
介入
入学 (推定)
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。
研究連絡先
- 名前:Beste Mutlu Dağlıoğlu
- 電話番号:+905546892608
- メール:drbeste.bm@gmail.com
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
説明
Inclusion Criteria:
- Patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective laparoscopic hysterectomy
- Body mass index (BMI) 18-35 kg/m²
- Ability to understand and use the patient-controlled analgesia (PCA) device
- Ability to provide written informed consent
Exclusion Criteria:
- Refusal to participate
- Allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or ongoing anticoagulant therapy
- Chronic opioid use or opioid dependence
- Severe hepatic or renal insufficiency
- Pregnancy or breastfeeding
- Cognitive impairment or inability to communicate pain scores
- Body mass index (BMI) >35 kg/m²
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: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:独身
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:椎間関節ブロック
|
A linear ultrasound probe will be positioned along the medial border of spinous processes level of the T10 thoracic vertebrae.Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T10 level, will be identified.
Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes.
Proper needle placement will be confirmed with the injection of 1-2 mmL isotonic saline demonstrating separation within the intertransverse plane.
Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.
|
|
アクティブコンパレータ:M-TAPA Block
|
A linear ultrasound probe will be positioned obliquely along the costal margin at the level of the 10th costal cartilage.
Anatomical landmarks, including the costal cartilage, rectus abdominis muscle, transversus abdominis muscle, and internal oblique muscle will be identified.
Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle will be inserted toward the perichondrial plane beneath the 10th costal cartilage under ultrasound guidance.
Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline.
Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.
|
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 intensity (VAS score)
時間枠:0, 1, 4, 8, 12, and 24 hours after surgery
|
Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores represent greater pain intensity.
|
0, 1, 4, 8, 12, and 24 hours after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
レスキュー鎮痛法の要件
時間枠:術後24時間以内に
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術後24時間以内に
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術後悪心・嘔吐の先行性
時間枠:術後24時間以内に
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術後24時間以内に
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患者管理鎮痛法(PCA)による総オピオイド消費量
時間枠:術後24時間以内
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術後24時間以内
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Quality of recovery assessed using the QoR-15 questionnaire
時間枠:At 24 hours postoperatively
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Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which ranges from 0 to 150, with higher scores indicating better recovery.
|
At 24 hours postoperatively
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Potential Complications
時間枠:Within the first 24 hours postoperatively
|
Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, or infection) will be recorded.
|
Within the first 24 hours postoperatively
|
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Patient satisfaction
時間枠:At 24 hours postoperatively
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Patient satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied).
Higher scores indicate greater satisfaction.
|
At 24 hours 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。
スポンサー
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 (推定)
2026年11月18日
一次修了 (推定)
2027年9月30日
研究の完了 (推定)
2027年11月30日
試験登録日
最初に提出
2026年5月15日
QC基準を満たした最初の提出物
2026年5月15日
最初の投稿 (実際)
2026年5月20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15日
最終確認日
2026年5月1日
詳しくは
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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Dexa Medica Group完了
M-TAPA Blockの臨床試験
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Hitit University募集
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Istinye University募集
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Bakirkoy Dr. Sadi Konuk Research and Training Hospital積極的、募集していない