Impact of Bilateral Parasternal Infusion of Local Anesthetics in Patients With Respiratory Risk Factors Over the Length of Hospitalization and Morphine Sparing in the Intensive Care Unit After On-pump Coronary Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Evaluation of the duration of hospitalization in intensive care unit
研究概览
简要总结
Currently intravenous analgesics are used for postoperative analgesia. But the analgesia of these products is tempered by their adverse effects (sedation, confusion, nausea or vomiting, delayed transit, urinary retention and pruritus) which can slow down postoperative recovery.
The aim of this study is to evaluate the effectiveness of the administration of local anesthetics via two catheters placed during surgery, but also to study their benefit on respiratory function and therefore on recovery time and morphine sparing.
详细描述
Medical context:
Cardiac surgery and more specifically coronary bypass surgery are very painful postoperative surgeries, especially during the first 48 hours following the operation. These pains, present at rest, are increased when the patient is mobilized, during coughing, deep inspiration, chairing or mobilization in bed.
In cardiac surgery, it has been shown that respiratory complications remain a significant cause of morbidity and mortality. They can lead to an extension of the length of hospitalization and therefore an increase in hospital costs. Indeed, these are increased compared to other surgeries because of the sternotomy and the pain it causes, as well as the type of ventilation during extracorporeal circulation (sharp reduction or even stopping of mechanical ventilation).
Patients having, prior to surgery, risk factors for postoperative respiratory complications, present increased risks of pneumonia, postoperative atelectasis, pleurisy, re-intubation, mortality and therefore an additional cost of hospitalization.
Limiting postoperative pain allows better rehabilitation of the patient by improving patient mobilization, participation in respiratory physiotherapy and therefore potentially a reduction in respiratory complications.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will include adults over 18 years of age requiring on-pump coronary bypass surgery with at least one of the following respiratory risk factors:
- •BMI > or = 30 Kg / m2
- •Active or withdrawn smoking for less than 6 weeks
- •COPD documented by pulmonologist or respiratory function test (LVEF/ FVC <0.7 not reversible after bronchodilator)
- •Restrictive ventilatory disorders, defined by a CPT less than 80% of normal
- •Chronic respiratory failure, defined by a PaO2, at rest, in ambient air, less than 70 mmHg
- •Age > or = 75 years old
排除标准
- •Any patient meeting one of the following criteria will be excluded from the study:
- •Emergency surgery
- •Other operative procedure planned during the same intervention (for example vascular), apart from the saphenous sample
- •Aortic dissection
- •Preoperative renal failure with GFR <30 mL / min / 1.73 m2
- •Left heart failure with Ejection fraction <30%
- •Pulmonary arterial hypertension> 50 mmHg
- •Hepatic cytolysis with ALT or AST> 2N
- •ASA score > or = 4
- •Coagulopathy
- •Anticoagulants or antiaggregants not stopped in time (according to usual protocols) or with poorly performed or unjustified relay
- •Chronic use of opioids or history of drug addiction
- •Progressive pregnancy or breastfeeding
- •Inability to understand protocol and sign consent
- •Known allergy to one of the substances in the study protocol
- •Patients requiring assistance such as ECMO, intra-aortic counter pulsation balloon or Impella will be excluded from the protocol.
研究组 & 干预措施
WITH catheter
A "multi-perforated catheter" arm benefiting from opioid analgesia (Patient controlled Analgesia ((PCA)) morphine (bolus-only mode or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol associated with analgesia by continuous infusion of local anesthetics (ropivacaine) via two multi-perforated catheters
干预措施: multi-perforated catheter (Procedure)
WITHOUT catheter
A "control" arm benefiting from opioid analgesia (PCA morphine in bolus mode alone or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol.
干预措施: Classic procedure (Procedure)
结局指标
主要结局
Evaluation of the duration of hospitalization in intensive care unit
时间窗: Day 1
Study of the benefit of the administration of local anesthetics via two catheters placed during surgery on recovery time versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects, and can slow down postoperative recovery.
次要结局
- Evaluation of the pain at rest and on mobilization using a visual pain evaluation scale(Day 2)
- Evaluation of the total consumption of opioids(At 48 hours)
- Evaluation of the patient mortality(Day 30)
- Evaluation of the occurrence of the side effects of opioids(At 48 hours)