Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy in Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change of pain score during cough
研究概览
简要总结
The sternotomy site is the most painful area after cardiac surgery. Erector spinae plane block is effective in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. The bilateral erector spinae plane block could reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction. The research hypothesis is that a single shot bilateral erector spinae plane block could reduce pain during mobilization during the first 48 hours after cardiac surgery performed with sternotomy
详细描述
Background:
Pain after cardiac surgery is mostly localized at the sternotomy site. To improve postoperative pain management a number of technics involving loco-regional anesthesia have been developed. The epidural analgesia is the gold standard but the risk of epidural hematoma with heparinization in this surgery avoids its utilization in clinical practice. The paravertebral block can be used equally but there is a risk of pneumothorax. The erector spinae plane block could be a solution as it is a more superficial block. It's efficacity was proven in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. A bilateral erector spinae plane block after cardiac surgery could significantly reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction.
The main objective of this to study is to examine the efficacity of a single-shot bilateral erector spinae plane block on pain reduction during mobilization during the first 48 hours after cardiac surgery compared to a control group.
The primary outcome:
Pain scale at patient mobilization during the first postoperative 48 hours measured by numerical pain scale.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The patient will be under sedation during the block performance. Th nurse in charge to the patient will be absent during the block performance and the block will be realized by the practitioner who will not take care of the patient during his hospitalization
入排标准
- 年龄范围
- 18 Years 至 78 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 for aortic or mitral valve replacement either by biological or mechanical prothesis, coronary arterial bypass surgery (CABG).
- •Body Mass Index between 18,5 and 33kg/m² (extremity excluded)
- •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 or chirurgical act on ascending thoracic Aorta
- •Redo surgery.
- •Pregnant women
- •Protected minors or adults
- •Pre-existing psychiatric pathology including known states of opioid addiction
- •Long-term opioid medication (>1month)
- •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 allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates).
- •Known allergy or hypersensitivity to any of excipients of the study drugs or analgesia protocol
- •Refusal of the protocol
研究组 & 干预措施
Ropivacaine group
Performance of an echo-guided bilateral erector spinae block at the arrival in the intensive care unit with 20ml of Ropivacaine 2mg/ml in each side.
干预措施: Ropivacaine 0,2% Injectable Solution (Drug)
Control group
Performance of a sham block at the arrival in the intensive care unit with no drugs administration
干预措施: Control group (Other)
结局指标
主要结局
Change of pain score during cough
时间窗: From patient awakening to 48 hours later (one evalution every 4 hours)
Pain evaluation by a nurse with Numeric Rating Scale (with 0 = no pain; 10= maximum pain) during cough
次要结局
- Change of pain score during patient tourn in the bed (lateralization) for nursing(From patient awakening to 48 hours later (one evalution every 4 hours))
- Change of sternal pain score at rest(From patient awakening to 48 hours later (one evalution every 4 hours))
- Change of pain score during central venous pressure measuring(From patient awakening to 48 hours later (one evalution every 4 hours))
- Diaphragm thickness(The day before surgery, the first or second day after surgery and the seventh day after surgery)
- Satisfaction assessed by the Likert scale(48 hours after intervention)
- Spirometry measure of peak expiratory flow (PEF)(The day before surgery, the first or second day after surgery and the seventh day after surgery)
- Diaphragmatic excursion(The day before surgery, the first or second day after surgery and the seventh day after surgery)
- Digestive function(Up to 6 months after surgery (end of Hospital stay))
- Time of drain removal(Up to 6 months after surgery (end of Hospital stay))
- Postoperative complications(Up to 1 month after surgery)
- Change of dorsal pain evaluation at rest(From patient awakening to 48 hours later (one evalution every 4 hours))
- Opioid consumption(48 hours after intervention)
- Spirometry measure of forced vital capacity (FVC)(The day before surgery, the first or second day after surgery and the seventh day after surgery)
- Spirometry measure of forced expiratory volume in one second (FEV1)(The day before surgery, the first or second day after surgery and the seventh day after surgery)
- Spirometry measure of force expiratory flow 25% (FEF 25%), FEF 50%, FEF 75%, FEF 25-75%(The day before surgery, the first or second day after surgery and the seventh day after surgery)
- Diaphragm thickening fraction(Up to 6 months after surgery (end of Hospital stay))
- Spirometry measure of FEV1/FVC(The day before surgery, the first or second day after surgery and the seventh day after surgery)