Ultrasound-Guided Erector Spinae Plane Block Versus Thoracoscopically-Guided Intercostal Nerve Block in Video-Assisted Thoracoscopic Surgery

Официальное название

Prospective, Randomized Comparative Study of an Anesthesiological, Ultrasound-Guided "Erector Spinae Plane Block" (ESPB) Versus a Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) in "Video-Assisted Thoracoscopic" (VATS) Procedures, Evaluating Postoperative Analgesic Consumption, Postoperative Pain Perception, and Duration of the Procedure

Обзор

Effective postoperative pain management is essential after thoracic surgery. Insufficient pain control may impair breathing and coughing, increasing the risk of pulmonary complications such as collapsed lungs (atelectasis) or pneumonia. Although minimally invasive lung surgery (video-assisted thoracoscopic surgery, VATS) is less painful than open surgery, people can still have significant pain after the operation. The goal of this randomized comparative study is to compare two commonly used regional anesthesia techniques for pain control after VATS in adults. Researchers will compare an ultrasound-guided erector spinae plane block (ESPB), performed by anesthesiologists, to a thoracoscopically-guided intercostal nerve block (ICNB), performed by surgeons. Participants will: * Undergo elective VATS lung resection surgery * Receive either ESPB or ICNB, according to random assignment * Have the received amount of analgesics recorded during the first 24 hours * Have their pain levels assessed at predefined time points after surgery The main questions this study aims to answer are: * Does ESPB result in similar analgesic consumption in the first 24 hours after surgery? * Does ESPB provide similar postoperative pain relief compared to ICNB? * Is the time needed to perform ESPB similar to ICNB?

Подробное описание

Effective postoperative pain management is essential after thoracic surgery, as insufficient pain control may impair breathing and increase the risk of pulmonary complications such as atelectasis or pneumonia. Although video-assisted thoracoscopic surgery (VATS) is less invasive than open thoracotomy, patients may still experience significant postoperative pain.

This single-center, prospective, randomized non-inferiority study with two parallel arms compares two commonly used regional anesthesia techniques for perioperative pain management in adult participants undergoing elective VATS lung resections: the Erector Spinae Plane Block (ESPB) and the Intercostal Nerve Block (ICNB). Both techniques have been shown to reduce postoperative pain and opioid consumption. However, existing comparative studies have reported inconsistent results, and direct comparisons are limited by differences in techniques and study design.

After informed consent, participants are randomized preoperatively using a sealed-envelope system to receive either an ultrasound-guided ESPB or a thoracoscopically-guided ICNB.

The ESPB is performed by anesthesiologists before induction of general anesthesia, whereas the ICNB is performed intraoperatively by the surgeon under thoracoscopic visualization. Both interventions use a standardized dose of 25 mL ropivacaine 0.375% prior to the start of the surgical procedure. Perioperative anesthesia and analgesia management are standardized across both groups to ensure comparability and to minimize confounding effects.

The primary objective is to evaluate whether ESPB is non-inferior to ICNB with respect to postoperative analgesic consumption within the first 24 hours after surgery. The non-inferiority margin is defined as 5 mg piritramide within 24 hours. This margin was selected as it corresponds to the upper limit of a commonly used bolus dose in routine clinical practice and represents a clinically meaningful difference.

Secondary objectives include the comparison of postoperative pain perception within the first 24 hours and the duration of the chest wall block procedure. The incidence of postoperative nausea and vomiting (PONV) and procedure-related complications is also assessed.

The sample size calculation is based on the primary non-inferiority endpoint. Estimates of variability were derived from published data on postoperative opioid consumption following VATS. Using a one-sided significance level of 0.025, a statistical power of 90%, and a 1:1 allocation ratio, and accounting for a dropout rate of 10%, a total of 72 participants will be enrolled.

Statistical analysis will follow the non-inferiority design, comparing postoperative analgesic consumption between groups with respect to the predefined margin, while secondary outcomes will be analyzed using appropriate descriptive and inferential statistical methods.

Вмешательства

• Процедура Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB)
  The ultrasound-guided Erector Spinae Plane Block (ESPB) is performed by experienced anesthesiologists prior to induction of general anesthesia and before the start of surgery. Standard sterile precautions are applied. The fifth and sixth thoracic vertebrae are identified using anatomical landmarks and, if needed, ultrasound guidance. An ultrasound probe is positioned in a paramedian sagittal orientation approximately 2 cm lateral to the spinous process to visualize relevant anatomical structures
• Процедура Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB)
  The thoracoscopically-guided Intercostal Nerve Block (ICNB) is performed by the surgeon intraoperatively immediately after insertion of the thoracoscope and before the start of surgery. Standard sterile precautions are applied. The block is performed percutaneously under continuous thoracoscopic visualization. The needle is advanced to the intercostal space, targeting the neurovascular bundle in the costal groove. Injections are performed at the level of the trocar insertion and in the two inter

Первичные конечные точки

• Assessment of the postoperative analgesic consumption within the first 24 hours after surgery [Срок оценки: First 24 hours after surgery]

Вторичные конечные точки (2)

• Assessment of the postoperative pain perception using the Numeric Rating Scale (NRS) pain scale [Срок оценки: First 24 hours after surgery]
• Duration of the chest wall block [Срок оценки: Perioperatively]

Критерии участия

Критерии включения

• Provision of written informed consent
• Adults (≥ 18 years of age)
• Elective video-assisted thoracoscopic surgery (VATS) for pulmonary resection (e.g., lobectomy, segmentectomy, wedge resection)

Критерии исключения

• Lack of informed consent
• Language barrier
• Pregnancy or breastfeeding
• Known allergy to local anesthetics used in the study
• Infection at the injection site(s)
• History of complex chest wall surgery
• Revision surgery with a prior operation within the last 6 months
• Intraoperative conversion to open thoracotomy
• Chronic pain syndrome
• Fibromyalgia
• Chronic opioid use
• Chronic alcohol abuse
• Chronic substance abuse (e.g., THC, amphetamines, cocaine)
• History of psychiatric disorders (e.g., depression, schizophrenia)
• Impaired consciousness, cognition, or ability to communicate
• Known coagulopathy (including platelet count < 80,000/µL or prolonged PTT/aPTT >1.5× the upper limit of normal)
• Ongoing therapeutic anticoagulation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Sana Klinikum Offenbach — Offenbach

Идентификаторы

NCT: NCT07535697 · 2025-4161-evBO · 2025-4161-evBO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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