The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pain evaluation
研究概览
简要总结
The sternotomy site is the most painful site after cardiac surgery. Local infiltration of ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after sternotomy significantly reduces pain at rest and during mobilization, reduces opioids consumption, decreases postoperative complications, improves patient comfort and satisfaction and reduced hospital costs. In this study our hypothesis is to test the efficacity of local anesthetic administration via the catheters in the BLS position placed before the surgical incision.
详细描述
Goal of the study: Evaluation of the effectiveness of BLS technique on a composite endpoint (pain at rest, pain during patient mobilization and opioid consumption).
Open trial, therapeutic, prospective, monocentric. One group of patients who will benefits from the placement of two multihole catheters in BLS position:
- The ropivacaine group (40 patients): placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
- The control group (80 patients) from the two previous studies who underwent standard analgesia with PCA morphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo scheduled cardiac surgery with sternotomy: aortic or mitral valve replacement, biological or mechanical, coronary bypass surgery
- •Age under 85 years
- •Patients who have given their consent according to the methods described in Title II of the book of the first Public Health Code
- •Possession of Social Security insurance.
排除标准
- •Emergency surgery
- •Approach by thoracotomy
- •Heart transplant
- •Aortic dissection
- •Redo surgery.
- •Pregnant women
- •Refusal of the protocol
- •Protected minors or adults
- •Pre-existing psychiatric pathology including known states of opioid addiction
- •Long-term opioid medication
- •Physical or intellectual inability to use a PCA
- •Severe heart failure (ejection fraction less than 40% or PAH > 50 mmHg)
- •Preoperative cardiogenic shock
- •Severe preoperative chronic or acute renal failure with a creatinine clearance of less than 30 mL / min according to Cockroft's formula
- •Known hypersensitivity to local anesthetics or to any component of the catheter
- •Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates).
研究组 & 干预措施
Ropivacaine group
Administration of a bolus dose of ropivacaine, followed by a continuous infusion of ropivacaine during the first 48 hours postoperatively.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Pain evaluation
时间窗: Day 2 postoperatively.
The technique is considered as a fail if : pain rest \> 3.5 /10 (0 = no pain; 10 maximum pain) or pain during mobilization \> 3.5/10 (0 = no pain; 10 maximum pain)
Opioid consumption
时间窗: Day 2 postoperatively.
The technique is considered as a fail if morphine consumption \> 35 mg
次要结局
- ICU length of stay(Up to 6 months)
- Hospital length of stay(Up to 6 months)
- Postoperative nausea and vomiting(Day 1 and 2 postoperatively.)
- Respiratory complications(Up to 6 months)
- Cardiac complications(Up to 6 months)
- Neurological complications(Up to 6 months)
- Renal,complications(Up to 6 months)
- Infectious complications(Up to 6 months)
- Patient satisfaction(Day 2 postoperatively.)
- Chronic pain evaluation(Assessed at the 6th postoperative month)