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Идёт набор NCT07315308

Preoperative Deep Parasternal Intercostal Plane Block and Intraoperative Opioid Use in Cardiac Surgery

Без фазы С лечением Postoperative Pain Sternotomy Opioid Consumption Intraoperative Pain Control

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Deep Parasternal Intercostal Plane Block, Standard Multimodal Analgesia.
Кому может быть актуально
Состояния в реестре: Postoperative Pain, Sternotomy, Opioid Consumption, Intraoperative Pain Control. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Preoperative Ultrasound-Guided Deep Parasternal Intercostal Plane Block Reduces Intraoperative Opioid Consumption in Adults Undergoing Cardiac Surgery Via Median Sternotomy

Обзор

Median sternotomy is commonly used in cardiac surgery and is associated with significant intraoperative and postoperative pain, often requiring substantial opioid administration. High opioid use during cardiac surgery may contribute to adverse effects such as respiratory depression, delayed extubation, postoperative nausea and vomiting, and prolonged intensive care unit stay. Therefore, effective opioid-sparing strategies are an important component of modern perioperative care. The deep parasternal intercostal plane (DPIP) block is a regional anesthesia technique that targets the anterior cutaneous branches of the intercostal nerves, which are responsible for transmitting pain from the sternum and adjacent tissues. When performed under ultrasound guidance, this block allows precise local anesthetic deposition while minimizing the risk of pleural or vascular injury. The purpose of this randomized controlled study is to evaluate whether a preoperative ultrasound-guided DPIP block reduces intraoperative opioid consumption in adult patients undergoing elective cardiac surgery via median sternotomy. Patients will be randomly assigned to receive either a bilateral DPIP block in addition to standard general anesthesia or standard general anesthesia alone. The primary outcome of the study is total intraoperative opioid consumption. Secondary outcomes include time to extubation, postoperative opioid consumption within the first 24 hours, postoperative pain scores, and the incidence of opioid-related adverse effects. The results of this study may help define the role of the DPIP block as part of a multimodal, opioid-sparing analgesic strategy in cardiac surgery.

Подробное описание

Adequate pain control during and after cardiac surgery via median sternotomy remains challenging despite advances in perioperative care. Opioids continue to be the mainstay of analgesia; however, excessive intraoperative opioid administration has been associated with delayed extubation, respiratory complications, postoperative nausea and vomiting, and prolonged intensive care unit stay. As part of enhanced recovery protocols, regional anesthesia techniques that provide effective opioid-sparing analgesia are increasingly emphasized.

The deep parasternal intercostal plane (DPIP) block is a relatively novel ultrasound-guided regional anesthesia technique that targets the anterior cutaneous branches of the intercostal nerves within the fascial plane between the internal intercostal and transversus thoracis muscles. Compared with more proximal neuraxial or paravertebral techniques, the DPIP block offers a more localized and anatomically specific approach to sternotomy-related pain while potentially reducing the risk of serious complications.

In this prospective, randomized controlled trial, adult patients scheduled for elective cardiac surgery via median sternotomy will be allocated to one of two parallel groups. Patients in the intervention group will receive a bilateral ultrasound-guided DPIP block performed preoperatively after induction of general anesthesia, in addition to standardized general anesthesia management. Patients in the control group will receive standardized general anesthesia alone, without a regional block. Perioperative anesthetic management, including opioid administration, will follow institutional protocols and will be guided by routine clinical parameters.

The primary objective of the study is to assess the effect of the preoperative DPIP block on total intraoperative opioid consumption. Secondary objectives include evaluation of early recovery parameters such as time to extubation, postoperative opioid requirements within the first 24 hours, postoperative pain intensity, and the occurrence of opioid-related adverse events. Safety outcomes related to the block procedure will also be recorded.

This study is designed to provide clinically relevant data on the role of the DPIP block as part of a multimodal analgesic strategy in cardiac surgery. By focusing on intraoperative opioid consumption and early recovery outcomes, the trial aims to clarify whether preoperative application of this targeted regional technique can contribute to improved perioperative management and opioid-sparing anesthesia in patients undergoing median sternotomy.

Вмешательства

  • Процедура Deep Parasternal Intercostal Plane Block
    Bilateral ultrasound-guided deep parasternal intercostal plane block performed after induction of general anesthesia, with injection of local anesthetic into the fascial plane between the internal intercostal and transversus thoracis muscles for postoperative analgesia.
  • Другое Standard Multimodal Analgesia
    Standard postoperative multimodal analgesia administered according to institutional cardiac anesthesia protocols, without any regional anesthesia technique.

Первичные конечные точки

  • Total Intraoperative Opioid Consumption [Срок оценки: From induction of general anesthesia until completion of surgery]
Вторичные конечные точки (5)
  • Intraoperative Hemodynamic Stability [Срок оценки: During surgery]
  • Time to Extubation [Срок оценки: From completion of surgery to successful tracheal extubation in the intensive care unit]
  • Postoperative Opioid Consumption [Срок оценки: First 24 hours postoperatively]
  • Time to First Rescue Analgesia [Срок оценки: Up to 24 hours postoperatively]
  • Block-Related Complications [Срок оценки: Intraoperative period and first 24 postoperative hours]

Критерии участия

Критерии включения

Adults aged 18 to 65 years Scheduled to undergo elective cardiac surgery via median sternotomy Planned general anesthesia Able to provide written informed consent

Критерии исключения

Known allergy or contraindication to local anesthetics Coagulation disorders or ongoing anticoagulant therapy that contraindicates regional anesthesia Infection at or near the planned injection site Pre-existing chronic pain conditions requiring long-term opioid use Severe cognitive impairment or inability to communicate pain intensity Emergency surgery Refusal or inability to provide informed consent

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
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Gaziantep Sehir Hastanesi — Gaziantep

Публикации

  • Medeiros HJS, Rodrigue ACLF, Mueller A, Korn E, Sabouri AS. Analgesic efficacy of parasternal intercostal plane block for midline sternotomy in adult cardiac surgery: A systematic review and meta-analysis of randomized controlled trials. J Biol Methods. 2024 Nov 14;12(1):e99010033. doi: 10.14440/jbm.2024.0070. eCollection 2025. PMID 40200942
  • Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30. PMID 38148266
  • Li Q, Liao Y, Wang X, Zhan M, Xiao L, Chen Y. Efficacy of bilateral catheter superficial parasternal intercostal plane blocks using programmed intermittent bolus for opioid-sparing postoperative analgesia in cardiac surgery with sternotomy: A randomized, double-blind, placebo-controlled trial. J Clin Anesth. 2024 Aug;95:111430. doi: 10.1016/j.jclinane.2024.111430. Epub 2024 Mar 26. PMID 38537393

Идентификаторы

NCT: NCT07315308 · 390

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗