Evaluation of the Effectiveness of Ultrasound-Guided Stellate Ganglion Block in Cardiac Surgery Anesthesia on Postoperative Recovery (ECLAIR)
Evaluation of the Effectiveness of Ultrasound-Guided Stellate Ganglion Block in Cardiac Surgery Anesthesia on Postoperative Recovery: A Multicenter, Randomized, Double-Blind Trial
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Pierre-Alain BAHR
- 电话号码:+33 03.80.29.30.79
- 邮箱:pierre-alain.bahr@chu-dijon.fr
学习地点
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Dijon、法国
- CHU Dijon Bourgogne
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接触:
- Pierre-Alain BAHR
- 电话号码:+33 03.80.29.30.79
- 邮箱:pierre-alain.bahr@chu-dijon.fr
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Ultrasound-Guided Stellate Ganglion Block (SGB) Group under general anesthesia
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Patient scheduled to undergo surgery (≥ 24 hours) involving cardiopulmonary bypass (CPB) for more than two procedures
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其他:Control group under general anesthesia
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Patient scheduled to undergo surgery (≥ 24 hours) involving cardiopulmonary bypass (CPB) for more than two procedures
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间:24 hours after surgery
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The French Quality of Recovery-15 questionnaire is a self-reported measure of overall postoperative recovery.
The tool contains 15 questions covering 4 dimensions: physical comfort (5 items), emotional state (4 items), pain (2 items), physical autonomy (2 items), and psychological support (2 items).
Each item is rated on a scale of 0 to 10, and the overall score is the sum of the scores obtained for each item, allowing for the classification of recovery quality: 0-89 ("extremely poor QoR"), 90-121 (moderate QoR), 122-135 ("good QoR"), and 136-150 ("excellent QoR").
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24 hours after surgery
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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