Does Bilateral Continuous Peri Operative Erector Spinae Plane Block Improve The Enhanced Recovery Program After Open Heart Surgeries in Adults?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Length of post operative stay in Hospital
研究概览
简要总结
To demonstrate if the addition of peri-operative regional analgesia by Bilateral ESP catheters improves the enhanced recovery program after open heart surgeries for the duration of hospitalisation, quality of analgesia, Consumption of peri-operative opioids, quality of recovery and quality of life.
Patients will be randomly divided in 2 groups Group 1 With the actual standards of care for enhanced recovery after cardiac surgery including opioid sparing peri operative analgesia Group 2 With the actual standards of care for enhanced recovery after cardiac surgery replacing the opioid analgesia by a peri operative analgesia by bilateral ESP catheters
详细描述
I. CONSULTING PHASE: 1 WEEK BEFORE SURGERY
- Preoperative information, education and counselling: patient and families receive dedicated preoperative counselling including information packets.
- Preoperative optimization: medical optimization before surgery, including renal, pulmonary, and endocrine function.
- Smoking and alcohol cessation: smoking and alcohol cessation advised and promoted before surgery.
- Preoperative nutrition status: patients screened for nutritional status and counselling given for a protein-rich diet at least the week before the surgery.
II. PREOPERATIVE PHASE: 2 DAYS BEFORE SURGERY
- Preoperative fasting and carbohydrate treatment: patients are kept NPO 8h before surgery except for oral carbohydrate beverage given 2-4h before surgery.
- Reviewed all examination results: cardiac echography, X-ray, biology's tests
- Consents signed.
- Authorization operative be signed
- Preoperative multimodal analgesic initiated : before surgery 2 h Gabapentin: 600 mg (P.O) Acetaminophen: 500 mg (P.O) Hydroxyzine: 50 mg (P.O)
III. INTRAOPERATIVE PHASE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open heart surgeries: Valvulopathies ( 1-2 valves, repair or replacement)
- •Congenital heart disease (Risk Adjustment in Congenital Heart Surgery Category 1-2 ( VSD, ASD, T4F)
- •Fraction ejection > 50%,
- •PAPS < 50 mmHg.
- •Age from 18-60 years old.
- •Consent participation
排除标准
- •Refusal participation.
- •Allergy to LA
- •Severe thoracic Scoliosis
- •Valvulopathies association with :
- •BENTALL procedure
- •Deficit mental
- •Alcoholics,
- •Heroine addicted
- •Insufficient renal
- •liver failure
- •Endocarditis <1 year
- •Stroke <3 months
- •MI <3 months
- •Bloc AV II or III with Pacemaker permanent
结局指标
主要结局
Length of post operative stay in Hospital
时间窗: 10 days
Duration of hospitalisation
次要结局
- Length of post operative stay in Intensive care unit(3 days)
- Time to 1st mobilisation(3 days)
- Quality of recovery(1 month)
研究者
Philippe Macaire
MD
Vinmec Healthcare System