Management of Postsurgical Pain After Cardiac Operations: Comparison of Tapentadol and Tramadol Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- change from baseline in pain score during coughing
研究概览
简要总结
The aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain) in cardiac surgery patients
详细描述
Management of post-surgical pain is a daily challenge for every anaesthetist. Undertreated post-surgical pain can result in cardiovascular, pulmonary and gastrointestinal complications, as well as chronic pain and negative psychological effects. A negative impact may be seen on immune function, coagulation and wound healing. Opioids have been the cornerstone in the treatment of pain after cardiac surgery. However, opioids have a number of adverse effects such as respiratory depression, gastrointestinal alterations, dizziness, delirium, addiction.
Tapentadol is a new synthetic opioid with dual mechanism of action. It acts as a mu-receptor agonist, as well as norepinephrine reuptake inhibitor. It is used to treat moderate to severe pain and is associated with fewer adverse effects compared to other opioids.
The aim of this randomized one-blinded study will be to evaluate the efficacy and tolerability of two different oral doses of tapentadol and compare it to tramadol (an opioid commonly used to treat post-surgical pain).
Patients undergoing cardiac surgery and being discharged from ICU to ward within 30 hours of surgery, will be divided into 3 groups. Group A will receive tapentadol 50mg p.o 3 times daily for two days, group B will receive tapentadol 75 mg p.o 3 times daily for two days and group C will receive tramadol 100 mg p.o 3 times daily for two days. Pain level will be assessed with Numeric Rating Scale (NRS), before drug administration and two hours after drug administration. Overall patient satisfaction will be assessed with Likert scale. Brief Pain Inventory( short form) and DN4 questionnaire will be used to detect chronic pain and neuropathic pain respectively, 3 and 6 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age <75 years old
- •patients discharged from Intensive Care Unit (ICU) in less than 30 hours
- •elective cardiac surgery
排除标准
- •hepatic failure (increased transaminase levels
- •renal failure (creatinine> 2 mg/dL)
- •emergency surgery (hemorrhage, tamponade, aortic dissection)
- •readmission in ICU
- •treatment with monoaminoxidase inhibitors, selective serotonine reuptake inhibitors or antiepileptics
- •age>75 years old
- •communication or language barriers
- •Lack of informed consent
研究组 & 干预措施
tapentadol 50 mg
tapentadol 50mg p.o 3 times daily for two days
干预措施: Group tapentadol 50 mg (Drug)
tapentadol 75 mg
tapentadol 75 mg p.o 3 times daily for two days
干预措施: group tapentadol 75 mg (Drug)
tramadol 100 mg
tramadol 100 mg p.o 3 times daily for two days
干预措施: group tramadol 100 mg (Drug)
结局指标
主要结局
change from baseline in pain score during coughing
时间窗: 2 hours after analgesia administration
pain score will be assessed by the use of Numeric Rating Scale (NRS) 2 hours after analgesia administration, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
side effects
时间窗: 2 hours after analgesia administration
side effects resulting from analgesic administration, yes or no
incidence of neuropathic pain 3 months after surgery
时间窗: 3 months after surgery
occurrence of neuropathic pain 3 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire
change from baseline in pain score at rest
时间窗: 2 hours after analgesia administration
pain score will be assessed by the use of Numeric Rating Scale (NRS) 2 hours after analgesia administration, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
incidence of chronic pain 3 months after surgery
时间窗: 3 months after surgery
occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Brief Pain Inventory Questionnaire
incidence of chronic pain 6 months after surgery
时间窗: 6 months after surgery
occurrence of chronic pain at the site of the operation 6 months after surgery, with the use of the Brief Pain Inventory Questionnaire
incidence of neuropathic pain 6 months after surgery
时间窗: 6 months after surgery
occurrence of neuropathic pain 6 months after surgery, with the use of the Douleur Neuropathique (DN4) Questionnaire
次要结局
- satisfaction from postoperative analgesia(72 hours postoperatively)
- hospitalization time(postoperatively, an average period of 10 days)
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital