NOL-Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Open Heart Surgery With Cardiopulmonary Bypass - A Propensity Matched Non-Inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fentanyl consumption (µg/kg)
研究概览
简要总结
This clinical trial focuses on an elaborate, propensity-matched, non-inferiority comparison of NOL-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Erector Spinae Plane Block (ESPB) within the context of open-heart surgery with cardiopulmonary bypass.
详细描述
A. Ethics
Local Ethics Committee approval and Informed Consent from patient or next-of-kin are obtained prior to study enrollment.
B. Study enrollment
Forty consecutive adult patients scheduled for elective open cardiac surgery under general anesthesia are to receive general anesthesia plus SPIPB. This prospective group of patients will be matched one-to-one to a historical group of 55 patients that underwent open cardiac surgery under general anesthesia combined with ESPB.
C. Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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.
- •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.
研究组 & 干预措施
SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)
Following induction, ropivacaine 0.5% (1.5 mg/kg per each side) with dexamethasone 8mg/20ml is deposited under ultrasound guidance in the plane between the intercostal muscles and the pectoralis major muscles, targeting the anterior cutaneous branches of the intercostal nerves.
干预措施: Superficial Parasternal Block (SIPB) (Procedure)
SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)
Following induction, ropivacaine 0.5% (1.5 mg/kg per each side) with dexamethasone 8mg/20ml is deposited under ultrasound guidance in the plane between the intercostal muscles and the pectoralis major muscles, targeting the anterior cutaneous branches of the intercostal nerves.
干预措施: General anesthetic (Drug)
SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)
Following induction, ropivacaine 0.5% (1.5 mg/kg per each side) with dexamethasone 8mg/20ml is deposited under ultrasound guidance in the plane between the intercostal muscles and the pectoralis major muscles, targeting the anterior cutaneous branches of the intercostal nerves.
干预措施: Morphine (Drug)
ERECTOR SPINAE PLANE BLOCK (ESPB)
Before induction, ropivacaine 0.5% (1.5 mg/kg per each side) with dexamethasone 8mg/20ml is deposited under ultrasound guidance between the transverse process of the 5th thoracic vertebra and the erector spinae muscle, targeting the dorsal and ventral rami of the spinal nerves.
干预措施: Erector Spinae Plane Block (ESPB) (Procedure)
ERECTOR SPINAE PLANE BLOCK (ESPB)
Before induction, ropivacaine 0.5% (1.5 mg/kg per each side) with dexamethasone 8mg/20ml is deposited under ultrasound guidance between the transverse process of the 5th thoracic vertebra and the erector spinae muscle, targeting the dorsal and ventral rami of the spinal nerves.
干预措施: General anesthetic (Drug)
ERECTOR SPINAE PLANE BLOCK (ESPB)
Before induction, ropivacaine 0.5% (1.5 mg/kg per each side) with dexamethasone 8mg/20ml is deposited under ultrasound guidance between the transverse process of the 5th thoracic vertebra and the erector spinae muscle, targeting the dorsal and ventral rami of the spinal nerves.
干预措施: Morphine (Drug)
结局指标
主要结局
Fentanyl consumption (µg/kg)
时间窗: during intraoperative period
Intraoperative opioid consumption after goal directed monitoring of nociception with the NOL index
Morphine consumption (µg/kg)
时间窗: 48 hours after surgery
Postoperative opioid consumption
次要结局
- Extubated patients(2 hours after surgery)
- 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 extubation(up to 24 hours after surgery)
- Norepinephrine dose (mcg/kg)(intraoperative, 6 hours and 12 hours after surgery)
- Time to weaning-off norepinephrine(up to 96 hours after surgery)
- Dobutamine dose (mcg/kg)(intraoperative, 6 hours and 12 hours after surgery)
- Time to first dose of morphine(any time for 48 hours)
- Norepinephrine-free patients(2 hours after surgery)
- Morphine-free patients(48 hours after surgery)
研究者
Balan Ion Cosmin
Principal Investigator
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu