Comparison of Erector Spinae Plane Block (ESPB) With the Combination of Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) in the Management of Postoperative Sternotomy Pain in Patients Undergoing Cardiac Surgery Via Sternotomy

Официальное название

Sternotomi İle Kardiyak Cerrahi Planlanan Hastalarda Postoperatif Sternotomi Ağrısının Yönetiminde Erektör Spina Plan Blok (ESPB) Ile Yüzeyel Parasternal İnterkostal Plan Bloğu (SPIPB) ve Serratus Anterior Plan Bloğu (SAPB) Kombinasyonunun Karşılaştırılması

Обзор

This study aims to compare the effectiveness of two regional anesthesia techniques in managing pain for participants undergoing cardiac surgery via sternotomy. The investigators will evaluate whether the Erector Spinae Plane Block (ESPB) or a combination of the Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) provides better pain control and recovery outcomes.

Подробное описание

The investigators aim to compare the effects of the erector spinae plane block (ESPB) versus the combination of superficial parasternal intercostal plane block (SPIPB) and serratus anterior plane block (SAPB) in the management of postoperative sternotomy pain among participants scheduled for cardiac surgery via sternotomy.

Study design and methods: A total of 50 participants (aged 18-80, ASA I-III) scheduled for sternotomy will be randomly assigned to one of two groups:

ESPB Group: Participants receive the Erector Spinae Plane Block. SPIPB + SAPB Group: Participants receive a combination of both blocks. Prior to the induction of general anesthesia, participants are randomized into two groups: the ESPB group and the SPIPB + SAPB group. Nerve blocks are performed in both groups. Visual Analog Scale (VAS) scores at rest and during coughing, intraoperative opioid consumption, postoperative behavioral pain scores, extubation times, and time to the first rescue analgesic requirement are evaluated.

Вмешательства

• Процедура Erector spinae plane block (ESPB)
  Bilateral ultrasound-guided ESPB is performed at the T4 or T5 vertebral level. Following skin preparation and visualization of the transverse process and erector spinae muscle, a block needle is inserted. After confirming the needle tip position between the muscle and the transverse process, 0.5 mL/kg of 0.25% Bupivacaine is injected on each side.
• Процедура Superficial Parasternal Intercostal Plane Block (SPIPB)
  Bilateral ultrasound-guided SPIPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for sternotomy.
• Процедура Serratus Anterior Plane Block (SAPB)
  Bilateral ultrasound-guided SAPB is performed. 0.25% Bupivacaine is administered. This is part of a combined regional analgesia technique for the chest wall.

Первичные конечные точки

• Pain Intensity (Visual Analog Scale Score) [Срок оценки: At 0, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively.]

Вторичные конечные точки (4)

• Extubation Time [Срок оценки: From the end of surgery until the date of successful endotracheal tube removal, assessed up to 24 hours.]
• Total Postoperative Opioid Consumption [Срок оценки: From the end of surgery up to 24 hours postoperatively.]
• Behavioral Pain Scale (BPS) [Срок оценки: From ICU admission until extubation, assessed up to 24 hours.]
• Time to First Rescue Analgesic [Срок оценки: From the end of surgery until the first dose of rescue analgesic, assessed up to 24 hours.]

Критерии участия

Критерии включения

• Patients aged between 18 and 80 years.
• Patients classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.
• Patients scheduled for elective cardiac surgery via median sternotomy.
• Patients who have provided written informed consent.

Критерии исключения

• Pregnancy or suspected pregnancy.
• Body Mass Index (BMI) > 35 kg/m².
• Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine).
• Suspected coagulopathy or bleeding disorders.
• Infection at the site of the regional block injection.
• Severe hepatic or renal failure.
• Severe neurological or psychiatric disorders.
• Emergency surgical procedures.
• Re-operation cases (Redo-surgery)

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

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Bursa Uludag University Hospital — Bursa

Публикации

• Yadav S, Raman R, Prabha R, Kaushal D, Yadav P, Kumar S. Randomized Controlled Trial of Ultrasound-Guided Parasternal Intercostal Nerve Block and Transversus Thoracis Muscle Plane Block for Postoperative Analgesia of Cardiac Surgical Patients. Cureus. 2024 Oct 23;16(10):e72174. doi: 10.7759/cureus.72174. eCollection 2024 Oct. PMID 39583527
• Zou M, Ruan W, Liu J, Xu J. Preemptive parasternal intercostal nerve block for patients undergoing off-pump coronary artery bypass grafting: a double-blind, randomized, controlled trial. Front Cardiovasc Med. 2023 May 18;10:1188518. doi: 10.3389/fcvm.2023.1188518. eCollection 2023. PMID 37273884
• Balan C, Boros C, Morosanu B, Coman A, Stanculea I, Valeanu L, Sefan M, Pavel B, Ioan AM, Wong A, Bubenek-Turconi SI. Nociception level index-directed superficial parasternal intercostal plane block vs erector spinae plane block in open-heart surgery: a propensity matched non-inferiority clinical trial. J Clin Monit Comput. 2025 Feb;39(1):59-72. doi: 10.1007/s10877-024-01236-0. Epub 2024 Oct 29. PMID 39470954
• Bousquet P, Labaste F, Gobin J, Marcheix B, Minville V. Bilateral Parasternal Block and Bilateral Erector Spinae Plane Block Reduce Opioid Consumption in During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Apr;35(4):1249-1250. doi: 10.1053/j.jvca.2020.07.021. Epub 2020 Jul 9. No abstract available. PMID 32843270
• Dost B, Kaya C, Turunc E, Dokmeci H, Yucel SM, Karakaya D. Erector spinae plane block versus its combination with superficial parasternal intercostal plane block for postoperative pain after cardiac surgery: a prospective, randomized, double-blind study. BMC Anesthesiol. 2022 Sep 16;22(1):295. doi: 10.1186/s12871-022-01832-0. PMID 36114466

Идентификаторы

NCT: NCT07472296 · 25-AKD-251

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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