Prospective, Randomized Clinical Pilot Study: Oral Opiate Targin In Treatment Of Postoperative Pain After Major Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- total opioid dosage in terms of so-called morphine equivalents
研究概览
简要总结
Postoperative pain and analgesic treatment still remains a challenge in daily perioperative medicine. Skin incisions, intraoperative tissue retraction and -dissection, intravasal cannulations and drainages, sternotomy and pericardiotomy are the most important reasons for postoperative pain. Poorly controlled pain can contribute directly or indirectly to postoperative complications, such as myocardial ischemia, pulmonary dysfunction like hypoventilation, pneumonia and atelectasis, a delayed return of gastrointestinal function and decreased mobility. In addition, prolonged acute pain also results in chronic pain.
Opioids are internationally recognized as the golden standard in the treatment of acute postoperative pain. On one side, the high potency of opioids in pain relief is clearly undisputed, but on the other hand, the administration of opioids is associated with nausea, vomiting, sedation and with the development of bowel dysfunction, which encompasses symptoms including bloating, abdominal spasm, cramps and constipation. Opioid-induced constipation is a frequently reported adverse effect and sometimes requires discontinuation of therapy, which results in analgesic under-treatment, severely impairing quality of life. However, there are many different regimes for the treatment of postoperative pain using opioids. Patient-controlled analgesia (PCA) using morphine is widely used, but requires trained staff and expensive equipment. Once patients are able to tolerate oral medications, the oral route is preferred postoperatively because it is more convenient, noninvasive and less expensive.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 90 years
- •ASA physical status 1-3
- •Elective major cardiac surgery requiring sternotomy
- •Oral and written consent
- •Postoperative extubation within four hours after arrival at the ICU
- •Cognitive ability in the use of the PCA pump and the VAS
排除标准
- •Chronic use of opioids in the last three months
- •Chronic use of tranquilizer or pain medications
- •Hypersensitivity against opioids
- •Use of monoamine oxidase inhibitors in the last two weeks before surgery
- •Alcohol or drug abuse
- •Renal dysfunction (GFR < 30 or necessity of dialysis)
- •Liver Dysfunction defined as Child-Pugh-Score 7-15
- •Ejection fraction (EF< 40%)
- •Malabsorption syndrome
- •Neurologic or cognitive dysfunction
- •Pregnancy
- •Participation in another clinical trial
- •Severe respiratory depression with hypoxia and/or hypercapnia
- •Severe chronic obstructive pulmonary disease
- •Severe bronchial asthma
- •Non-opioid induced paralytic ileus
- •Risk of seizures
研究组 & 干预措施
Targin/OxyNorm
Patients randomized to this study arm will receive Targin as basis pain medication and additional OxyNorm (Oxycodone), if requested by the patients.
干预措施: Targin (Drug)
Targin/OxyNorm
Patients randomized to this study arm will receive Targin as basis pain medication and additional OxyNorm (Oxycodone), if requested by the patients.
干预措施: Oxynorm (Drug)
PCA
Patients randomized to this group will receive a PCA pump with morphine. The basic rate is 0.3 mg/h. Patients will be allowed to administer 1 mg each five minutes after a vesting period of five minutes, if subjectively needed.
干预措施: Morphine (Drug)
结局指标
主要结局
total opioid dosage in terms of so-called morphine equivalents
时间窗: 3 days
total administrated opioid dosage during 3 days after surgery
次要结局
- in hospital stay(1 month)
- ICU stay(1 month)
- possible side effects(3 days)
- VAS pain score(3 days)
- level of sedation(3 days)
- rate of spontaneous breathing(3 days)
研究者
Kurt Rutzler
senior staff physician
Medical University of Vienna
