Comparison of Pain and Comfort in Patients Following Cardiac Surgery: Opioid- Morphine Managed Versus Multimodal Pain-management
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative Pain After Cardiac Surgery
研究概览
简要总结
To compare standard "Fentanyl - Tramadol - Paracetamol - Oxycodone" regimen to a multimodal painmanagement "pregabalin- minimal fentanyl-ketamine-lidocain-dexmedetomidine- paracetamol" to determine which therapy provides the most comfort, the fastest extubation time, the least pain and the least delirium.
详细描述
Cardiac surgery for the adult, performed by sternotomy is associated with moderate to severe acute postoperative pain. Postoperative pain is the primary reason for prolonged convalescence and one of the main concerns of the surgical patient in the Intensive Care Unit (ICU). This pain is multifactorial and multifocal; and can be caused by incision, intraoperative tissue retraction and dissection, surgical manipulation of the parietal pleura, posterior rib dislocation or fracture, possible brachial plexus injury, chest tube insertion and harvesting of the saphenous vein and internal mammarian artery.
The most common analgesic schemes for postoperative pain in cardiac surgery are based on intravenous opioids by bolus, with patient- or nurse-controlled delivery systems. Although there is no doubt they have a beneficial effect on pain, opioids are associated with dose-related side effects including "over"sedation, ileus, urinary retention, nausea, vomiting, pruritus, mental confusion and respiratory depression leading to a prolonged extubation time.
In the last decades many has been written about the value of multimodal pain protocols to treat acute postoperative pain in non-cardiac surgery. This is not only to reduce the dose and side effects of opioids. By blocking both the central and peripheral pain mechanisms the aim is to find a holy grale, by which the patient suffers the least, by which central neural hyper-excitability that increases postoperative pain is minimized and by which the transformation of acute into chronic pain is reduced to a minimum.
Pregabalin has his role in treating various neuropathic pain syndromes. It inhibits central neuronal sensitization and prevents hyperalgesia by decreasing excitatory amino acid neurotransmission in the spinal cord through a direct postsynaptic or presynaptic inhibition of Ca²+ influx. It has been shown that gabapentin reduced pain scores and opioid requirements in different surgical settings. Literature is not conclusive and because of conflicting results the routine use of gabapentin and pregabalin to reduce opioid consumption in the cardiac surgical patients is not yet recommended.
Dexmedetomidine is an alpha-2 adrenergic receptor agonist that can be directly applied to the peripheral nervous system, causing a dose-dependent inhibition of C-fibers and Aα-fibers. It is widely used for sedation and anxiolysis in ICU settings. The clinical efficacy has been proven in non-cardiac surgery by augmenting anesthesia and analgesia, and allowing a reduction in opioid requirements. Additionally, there was a significantly lower incidence of postoperative delirium.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing first time cardiac surgery by median sternotomy
- •Elective surgery or semi-urgent: there needs to be time to provide 1 hour before surgery the intake of pregabalin
- •≥ 18 years for men
- •Women who are in menopause
- •Possibility to communicate with the patient to score pain and comfort
- •Signed Informed Consent, signed by subject able and willing to provide written informed consent for study participation
排除标准
- •Urgent surgery
- •Women who are in premenopause
- •Hypersensitivity to any of the study medication
- •In case of direct postoperative revision the patient is NOT excluded.
研究组 & 干预措施
Multimodal protocol
Lyrica (Pregabalin) 75mg PO 2 hours before the operation
Dexdor (Dexmedetomidine) 0.8µg/kg/h IV Per-operative / Post-operative
Ketalar (Ketamine) Bolus (0.5mg/kg) + 0.3mg/kg/h IV Per-operative until stop propofol
Linisol (Lidocain) Bolus (1.5mg/kg) + 1.3mg/kg/h IV Per-operatiive until 12h post-op
Magnesium Sulphate Induction (25mg/kg) + 25mg/kg weaning ECC IV Per-operative
Fentanyl 2.5µg/kg IV Per-operative
Paracetamol 4x1g /24u IV Post-operative
Tradonal (Tramadol) 100mg IV 4/d IV Post-operative in case of Break through pain
Oxynorm (Oxycodon) 5-10mg 4-6/d PO Post-operative in case of Break through pain
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Postoperative Pain After Cardiac Surgery
时间窗: At 48 hours after cardiac surgery
By using a NRS scale postoperative pain (at rest) at 48hours after cardiac surgery In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 . Zero usually represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.
次要结局
- (ICDSC)Delirium After Stop Sedation by Using Intensive Care Delirium Screening Checklist(At 48 h after surgery)
