Studio Randomizzato Prospettico Comparativo di 2 Tecniche di Analgesia Loco-regionale Per Interventi di Cardiochirurgia Con Approccio Mini-toracotomico
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Subjective quality of the postoperative period
研究概览
简要总结
Optimization of postoperative analgesia and reduction of opioid consumption are key components of Enhanced Recovery After Surgery (ERAS) protocols in cardiac surgery. Although intravenous opioids have traditionally been the mainstay of analgesic management due to their potent analgesic effect and hemodynamic stability, high-dose opioid use has been associated with respiratory depression, prolonged mechanical ventilation, delayed extubation, longer intensive care unit stay, and multiple short- and long-term adverse effects.
Thoracic wall loco-regional anesthesia techniques represent promising opioid-sparing strategies in minimally invasive cardiac surgery performed via mini-thoracotomy.
The purpose of this prospective randomized study is to compare two loco-regional analgesic techniques - the Erector Spinae Plane (ESP) block and the Serratus Anterior Plane (SAP) block - in adult patients undergoing minimally invasive cardiac surgery.
The study aims to determine whether one technique is superior in reducing postoperative morphine consumption, improving pain control, and enhancing patient-reported quality of recovery as measured by the Italian Quality of Recovery (iQoR) questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age undergoing cardiac surgery via a mini thoracotomy approach
- •patient agreement to participate in the protocol and sign the informed consent.
排除标准
- •patients with psychiatric disorders
- •patients who have already undergone surgery involving the chest wall
- •patients suffering from chronic pain already undergoing home therapy
- •allergy to NSAIDs/paracetamol
- •absence of informed consent
- •participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the five half-lives of the study drug (whichever is longer)
- •pregnant women.
研究组 & 干预措施
Serratus Plane Anterior Block (SAP)
The Serratus Anterior Plane (SAP) block is performed with the patient in the supine or lateral position, using a Stimuplex Ultra 360 needle (22G × 80 mm), under ultrasound guidance with a 5-10 MHz linear probe.
干预措施: Analgesia (Procedure)
Erector Spinae Plane (ESP)
The Erector Spinae Plane (ESP) block is performed with the patient in the sitting or lateral position, using a Stimuplex Ultra 360 needle (22G × 80 mm), under ultrasound guidance with a 5-10 MHz linear probe.
干预措施: Analgesia (Procedure)
结局指标
主要结局
Subjective quality of the postoperative period
时间窗: FROM THE DAY OF THE SURGERY FOR THE FOLLOWING 48 HOURS.
The primary outcome was patient-reported quality of postoperative recovery, assessed with the Italian Quality of Recovery questionnaire (iQoR-15) on postoperative days 1 and 2. The QoR-15 is a validated 15-item instrument measuring five domains: pain, physical comfort, independence, emotional state, and psychological support. Scores range from 0 (poor recovery) to 150 (excellent recovery). It has strong psychometric properties, including validity, reliability, and responsiveness, and provides a comprehensive evaluation of recovery beyond complications, helping predict adverse outcomes and prolonged hospital stay. The QoR-15 is a shortened version of the QoR-40, takes about 2.5 minutes to complete, and the validated Italian version (iQoR-15) was used for Italian-speaking patients.
次要结局
- Efficacy of pain contrrol(FROM THE DAY OF THE SURGERY FOR THE FOLLOWING 48 HOURS.)