Sternotomy PIFB Block in Open Heart Surgery

Официальное название

Efficacy of Bilateral Pecto-Intercostal Fascial Plane Block on Postoperative Pain in Adult Patients Undergoing Open Heart Surgery: A Randomized, Double-blind, Controlled Trial

Обзор

The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia \[MMA\]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "Pecto-Intercostal Fascial Block \[PIFB\]") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.

Подробное описание

Study design This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.

Study participants Adult patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center with an American Society of Anesthesiologists (ASA) physical status of I to IV who are scheduled to undergo open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center.

Sample size Eighty-four subjects who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria will be included in a single treatment group.

Вмешательства

• Процедура Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine
  The US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm need
• Процедура Pecto-intercostal Fascial Block with normal saline
  The US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm need

Первичные конечные точки

• OPIOID consumption at 24 hours [Срок оценки: 24 hours after block procedure]
• OPIOID consumption during surgery [Срок оценки: Surgery length]
• NRS pain score at 48 hours [Срок оценки: Up to 48 hours after block procedure]
• Worst pain score at 48 hours [Срок оценки: Up to 48 hours after block procedure]
• Incidence nausea and/or vomiting after surgery [Срок оценки: Up to 48 hours after block procedure]
• Self-reported satisfaction score at 48 hours [Срок оценки: 48 hours after block procedure]
• pain-DETECT scores at 90 days [Срок оценки: Up to 90 days after block procedure]

Критерии участия

Критерии включения

• Adult male or female patients aged > 18
• Undergoing primary cardiac surgery requiring sternotomy
• Able to provide a signed written informed consent
• Able to speak, read, and write in English
• American Society of Anesthesiologists (ASA) physical status I-IV

Критерии исключения

• Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception
• Diabetes Mellitus with documented neuropathic pain
• Vulnerable populations: pregnant females, prisoners, breast feeding
• Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone
• Previous cardiac surgery
• Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery
• Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study
• BMI ≥ 40 kg/m2

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

США · 1 центр

• The Ohio State University Wexner Medical Center — Columbus

Идентификаторы

NCT: NCT06233318 · 2023H0076

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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