Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Surgery (VATS)

Официальное название

Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Surgery (VATS): a Randomised, Double-blind Study

Обзор

Video-assisted thoracoscopic surgery (VATS) is associated with significant postoperative pain despite lower morbidity compared with thoracotomy. Adequate pain management is essential within Enhanced Recovery After Surgery (ERAS) pathways to preserve respiratory function and facilitate postoperative recovery. Surgical intercostal block performed under direct vision is a simple and effective regional analgesic technique commonly used following VATS. However, the optimal timing of intercostal block administration during surgery remains uncertain. This prospective randomized double-blind study will compare surgical intercostal block performed at the beginning versus the end of the surgical procedure. The study aims to evaluate the effect of block timing on postoperative pain intensity and postoperative opioid consumption. The results may help optimize multimodal analgesic strategies in patients undergoing thoracic surgery.

Вмешательства

• Процедура Intercostal nerve block before (ropivacaine 0.375%)
  All patients will receive two intercostal nerve blocks using the same injection volume and technique. Intercostal nerve blocks will be performed twice: before surgical incision and at the end of the procedure. In both study groups, one injection will contain ropivacaine 0.375% and the other will contain normal saline. In the interventional arm, the pre-incision intercostal nerve block will contain the local anesthetic, whereas the end-of-procedure intercostal nerve block will contain normal sal
• Процедура Intercostal Nerve Bloc before (physiological serum)
  All patients will receive intercostal nerve blocks using the same local anesthetic (ropivacaine 0.375%). Intercostal nerve blocks will be performed twice: before surgical incision and at the end of the procedure. In the interventional arm, the pre-incision intercostal nerve block will contain the local anesthetic, whereas the end-of-procedure intercostal nerve block will contain normal saline. In the comparator arm, the pre-incision intercostal nerve block will contain normal saline, whereas th
• Процедура ICNB after (ropivacaine 0.375%)
  All patients will receive intercostal nerve blocks using the same local anesthetic (ropivacaine 0.375%). Intercostal nerve blocks will be performed twice: before surgical incision and at the end of the procedure. In the interventional arm, the pre-incision intercostal nerve block will contain the local anesthetic, and the end-of-procedure intercostal nerve block will contain normal saline. In the comparator arm, the pre-incision intercostal nerve block will contain normal saline, and the end-of-
• Процедура ICNB after (physiological serum)
  All patients will receive an intercostal nerve block using the same local anesthetic (ropivacaine 0.375%). ICNB will be performed twice: before surgical incision and at the end of the procedure. In the interventional arm, the ICNB before surgery will contain the local anesthetic, and the ICNB after surgery will contain normal saline. In the comparator arm, the ICNB before surgery will contain normal saline, and the ICNB after surgery will contain the local anesthetic.

Первичные конечные точки

• Postoperative pain intensity during the first 24 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS) [Срок оценки: At 24 hours postoperatively]
• Postoperative pain intensity during the first hour following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS) [Срок оценки: At 1 hour postoperatively]
• Postoperative pain intensity during the first 6 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS) [Срок оценки: At 6 hours postoperatively]
• Postoperative pain intensity during the first 12 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS) [Срок оценки: At 12 hours postoperatively]

Вторичные конечные точки (7)

• Postoperative pain intensity during the first 48 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS) [Срок оценки: At 48 hours postoperatively]
• Postoperative pain intensity during the first 72 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS) [Срок оценки: At 72 hours postoperatively]
• incidence of chronic postoperative pain 3 months after video-assisted thoracoscopic surgery (VATS) [Срок оценки: At 3 months after surgery]
• Intraoperative blood pressure stability [Срок оценки: During video-assisted thoracic surgery]
• Intraoperative opioid consumption during video-assisted thoracoscopic surgery (VATS). [Срок оценки: From induction of anesthesia to the end of surgery]
• Incidence of postoperative complications during hospitalization. [Срок оценки: During hospitalization, up to 30 days]
• Incidence of adverse effects and complications related to intercostal block administration. [Срок оценки: From intercostal block administration until hospital discharge, up to 30 days]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Scheduled for single-port or two-port video-assisted thoracoscopic surgery (VATS).
• ASA classification 1 to 3
• Able to understand the study, describe their pain and provide valid informed consent

Критерии исключения

• Neurological or psychiatric conditions that compromise the reliable assessment of pain(dementia, cognitive impairment, severe communication disorders)
• Chronic opioid use or regular use (> 3 months) of strong analgesics for chronic pain
• History of allergy or known hypersensitivity to local anaesthetics
• Coagulopathy or anticoagulant therapy precluding the safe performance of an intercostal block
• Local infection at the injection site or active systemic infection
• Bilateral thoracic surgery or intraoperative conversion to thoracotomy
• Second surgery at the same site.
• Current pregnancy or breastfeeding
• Inability to understand postoperative instructions or a language barrier preventing a validated assessment of pain
• Simultaneous participation in another clinical trial involving analgesia or thoracic surgery
• Refusal to participate or withdrawal of consent at any time

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• HUB Erasme — Brussels

Идентификаторы

NCT: NCT07532681 · P2026/145

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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