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Intertransverse Process Block Versus Subcostal Transversus Abdominis Plane Block After Laparoscopic Sleeve Gastrectomy

2026年5月9日 更新者:Mustafa Kılın、Antalya City Hospital

Intertransverse Process Block Versus Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Controlled Trial

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Intertransverse Process Block (ITPB) and the Subcostal Transversus Abdominis Plane Block (TAPB) in patients undergoing laparoscopic sleeve gastrectomy. 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.

研究概览

详细说明

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 Subcostal Transversus Abdominis Plane Block (TAPB) on Visual Analog Scale (VAS) scores in patients undergoing laparoscopic sleeve gastrectomy. 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) >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 TAPB will receive a bilateral subcostal TAP block. All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), 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 T7/T8 thoracic vertebrae.

Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T7/T8 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.

Subcostal TAP Block:

The Subcostal Transversus Abdominis Plane Block (TAPB) 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 parallel to the lower costal margin.

Anatomical landmarks, including the rectus abdominis muscle, posterior rectus sheath, and transversus abdominis 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 into the fascial plane between the posterior rectus sheath and the transversus abdominis muscle.. 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-point Likert scale, where 1 = not satisfied and 5 = very satisfied, based on verbal feedback from both the patient and the surgeon.

Nausea and Vomiting: Nausea and vomiting will be scored using a 4-point scale:

0 = none

  1. = mild
  2. = moderate
  3. = severe

Potential Complications 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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients aged 18-65 years
  • ASA physical status I-III
  • Scheduled for elective laparoscopic sleeve gastrectomy
  • Body mass index (BMI) >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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Intertransverse Process Block (ITPB)

Ultrasound System, Model DC-T6) will be positioned along the medial border of spinous processes level of the T7/T8 thoracic vertebrae.

Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T7/T8 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 mL 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.

有源比较器:Subcostal Transversus Abdominis Plane Block (TAPB)

After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine. A linear ultrasound probe will be positioned parallel to the lower costal margin.

Anatomical landmarks, including the rectus abdominis muscle, posterior rectus sheath, and transversus abdominis muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle will be inserted into the fascial plane between the posterior rectus sheath and the transversus abdominis muscle. 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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Postoperative pain intensity (VAS score)
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
急救镇痛要求
大体时间:术后24小时内
术后24小时内
术后恶心呕吐的发生率
大体时间:术后24小时内
术后24小时内
通过患者自控镇痛(PCA)给药的总阿片类药物用量
大体时间:术后24小时内
术后24小时内
Quality of recovery assessed using the QoR-15 questionnaire
大体时间:At 24 hours postoperatively
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
Potential Complications
大体时间: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
Patient satisfaction
大体时间:At 24 hours postoperatively
Patient and surgeon 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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月30日

初级完成 (估计的)

2027年12月30日

研究完成 (估计的)

2028年5月30日

研究注册日期

首次提交

2026年5月9日

首先提交符合 QC 标准的

2026年5月9日

首次发布 (实际的)

2026年5月15日

研究记录更新

最后更新发布 (实际的)

2026年5月15日

上次提交的符合 QC 标准的更新

2026年5月9日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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