Combined Erector Muscle Spinae Plane Block and General Anaesthesia Versus General Anaesthesia Alone - Effect on Perioperative Opioid Consumption in Open Heart Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Intraoperative fentanyl consumption (µg/kg/h)
研究概览
简要总结
With the advent of ultrasound (US) guidance, use of regional anaesthesia (RA) is poised to grow and evolve. Recently, cardiac surgery has benefited from newer US guided interfascial techniques as they promise to fulfil all the prerequisites of an enhanced recovery after surgery (ERAS) strategy(1,2).
The erector spinae plane (ESP) block represents such an alternative(3). Speed and ease of performance are paramount to encourage spread of its use. Hence, the scope of this trial is to investigate the effects on perioperative opioid consumption and several other secondary outcomes of a minimalist approach encompassing a bilateral single shot ESP block when applied as an adjunct to general anaesthesia.
详细描述
DETAILED DESCRIPTION OF STUDY
A. Ethics
Local Ethics Committee approval and Informed Consent from patient or next-of-kin are obtained prior to study enrolment.
B. Study enrolment
Eighty adult patients scheduled for elective open cardiac surgery under general anaesthesia (GA) are randomly allocated to receive either GA plus ESP block (ESP group, n = 40) or GA alone (control group, n = 40).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent.
- •Elective heart surgery with sternotomy and bypass.
- •Hemodynamic stability prior to induction (no chest pain, SAP > 100 mmHg, MAP ≥ 60 mmHg, 50 < HR < 100 bpm).
- •Sinus rhythm.
排除标准
- •Known allergy to any of the medications used in the study.
- •Patient refusal to participate in the study.
- •Coagulopathy (INR > 1.5, APTT > 45, Fibrinogen < 150 mg/dl).
- •Non-elective/emergent and/or redo surgery.
- •Any preoperative hemodynamic support (mechanical or pharmaceutical).
- •Severe LV dysfunction (LVEF ≤ 30%).
- •Severe RV dysfunction or PHT (RVFAC ≤ 25%).
研究组 & 干预措施
General anesthesia alone (AG)
Opioid based analgesia:
Fentanyl 5 mcg/kg is standard dose at induction. Further dosing is steered according to NOL index and ancillaries such as heart rate and mean arterial blood pressure (± 20% of preoperative baseline).
Postoperatively, analgesia comprises on-demand morphine and regularly dosed paracetamol.
干预措施: General anesthetic (Drug)
Erector Spinae Plane Block and General Anaesthesia (ESPAG)
Bilateral single shot erector spinae plane block with Ropivacaine 0.5% (total dose 3mg/kg) and Dexamethasone 8mg per every 20ml Ropivacaine 0.5% is performed before induction of general anaesthesia. A minimum 30 minutes interval is allowed before skin incision.
Fentanyl 5 mcg/kg is standard dose at induction; rescue dosing is steered according to NOL index and ancillaries such as heart rate and mean arterial blood pressure (± 20% of preoperative baseline).
Postoperatively, analgesia comprises on-demand morphine and regularly dosed paracetamol.
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
结局指标
主要结局
Intraoperative fentanyl consumption (µg/kg/h)
时间窗: during intraoperative period
Goal directed monitoring of nociception with NOL index PMD200 (+/- variation of mean arterial blood pressure and heart rate)
次要结局
- Time to catecholamine - free state(up to 96 hours after surgery)
- Rate of atrial fibrillation(48 hours after ICU admission)
- Quality of postoperative analgesia(6 hours, 12 hours, 24 hours and 48 hours after extubation/ICU admission and 1 hour after drain removal)
- Time to removal of drain(up to 72 hours after surgery)
- Time to extubation(up to 24 hours after surgery)
- Rate of postoperative pneumonia(up to two weeks)
- Time to first out of bed(up to 72 hours after surgery)
- Rate of nausea and vomiting (PONV)(24 hours after ICU admission)
- Fentanyl (µg/kg/h) consumption(until large vessel cannulation)
- Morphine consumption (mg/kg)(24 hours and 48 hours after surgery)
- Rate of delirium(7 days after surgery)
- Norepinephrine dose (mcg/kg/h)(intraoperative, 6 hours and 12 hours after surgery)
研究者
Balan Ion Cosmin
Consultant in Cardiovascular Anaesthesia and ICM
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu