Evaluation of the Effectiveness of Ultrasound-Guided Stellate Ganglion Block in Cardiac Surgery Anesthesia on Postoperative Recovery

Официальное название

Evaluation of the Effectiveness of Ultrasound-Guided Stellate Ganglion Block in Cardiac Surgery Anesthesia on Postoperative Recovery: A Multicenter, Randomized, Double-Blind Trial

Обзор

Heart surgery is a complex and delicate procedure that affects more than one million people worldwide each year. Patients who undergo this surgery are generally elderly and have multiple comorbidities, which places them in high-risk categories (ASA III or IV). This frailty, combined with a loss of physiological reserve, makes these patients particularly vulnerable to postoperative complications, which can range from cardiovascular disorders to neurological, respiratory, renal, gastrointestinal, infectious, and hematological complications. In this context, the quality of postoperative recovery is crucial because it reflects the patient's postoperative health status. The quality of recovery encompasses several dimensions, such as pain, return to independence, sleep quality, and mental state. Optimal anesthesia-which goes beyond simply minimizing pain-requires proactive management of all these dimensions. Current research in cardiac surgery focuses on optimizing anesthesia strategies, particularly the choice between opioid and non-opioid anesthesia, as well as the complementary use of regional analgesia. However, studies providing clear recommendations on these topics are still limited. Among the techniques explored, the ultrasound-guided stellate ganglion block (SGB) stands out due to its numerous positive clinical effects. This block, which involves the ultrasound-guided injection of a local anesthetic into the stellate ganglion, produces a temporary sympathetic block that reduces the activity of the autonomic nervous system during surgery. Several studies suggest that SGB could significantly improve the quality of postoperative recovery, particularly in terms of pain reduction, sleep quality, and a lower incidence of cardiac arrhythmias. A meta-analysis has shown that SGB promotes the recovery of gastrointestinal function following various surgical procedures. In major thoracic surgery, it has been observed that SGB reduces the incidence of perioperative atrial and ventricular fibrillation. Although these results are promising, data from randomized trials in cardiac surgery are still limited. A pilot study demonstrated the feasibility and safety of SGB in this type of surgery, with a reduced incidence of atrial fibrillation. However, further studies are essential to confirm these results and assess the impact of SGB on the quality of recovery following anesthesia in cardiac surgery. The hypothesis of this study is that performing a stellate ganglion block during general anesthesia improves the quality of recovery in all its aspects (pain, well-being, sleep, etc.). This hypothesis warrants in-depth exploration to optimize postoperative care and improve long-term outcomes for patients undergoing complex cardiac surgery.

Вмешательства

• Процедура Elective surgery (≥ 24 hours) with cardiopulmonary bypass (more than 2 procedures)
  Patient scheduled to undergo surgery (≥ 24 hours) involving cardiopulmonary bypass (CPB) for more than two procedures

Первичные конечные точки

• Score obtained on the validated psychometric scale F-QoR-15 (French Quality of Recovery-15 questionnaire) at 24 hours post-surgery in the intervention group (general anesthesia + ultrasound-guided nerve block), compared with the control group (general an [Срок оценки: 24 hours after surgery]

Критерии участия

Критерии включения

• Individuals who have provided their free and informed written consent
• Age ≥18 years
• Patients scheduled to undergo elective cardiac surgery (≥24 hours) with cardiopulmonary bypass (CPB): valve surgery, aorto-coronary bypass surgery, or combined surgery (>2 procedures)

Критерии исключения

• Adult under guardianship
• Patient not enrolled in a social security program
• Patient who has previously been included in the study (e.g., repeat surgery)
• Patient with hypersensitivity to local anesthetics or to any of the excipients in the products used
• Preoperative AC/FA
• Hypovolemia
• Severe hypotension
• Acute porphyria
• Pregnant, laboring, or breastfeeding women

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

Профилактика

Центры проведения

Франция · 1 центр

• Chu Dijon Bourgogne — Dijon

Идентификаторы

NCT: NCT07676487 · BAHR PHRCI 2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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