EUCTR2019-001725-27-DE进行中（未招募）1 期
A randomized, open, three-arm comparative study of modern methods of postoperative pain therapy in patients with knee endoprostheses.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age: from 18 years
- •- Indication for implantation of a unilateral knee endoprosthesis
- •- Patients with (American Society of Anesthesiologists) ASA Score 1 to 3
- •- Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •- other endoprosthesis on a lower extremity with NRS > 4
- •- Patients with a previous spinal surgery
- •- inflammatory bowel diseases
- •- permanent intake of opioids WHO stage III (more than 6 weeks before the planned surgery)
- •- clinically relevant Obstructive Sleep Apnea Syndrome
- •- disorders of bone marrow function (e.g. after cytostatic treatment) or diseases of the haematopoietic system
- •- genetically determined glucose-6-phosphate dehydrogenase deficiency
- •- acute intermittent hepatic porphyria
- •- serious impairment of lung function, clinically relevant COPD, Cor pulmonale
- •- severe bronchial asthma, severe coagulation disorders or other contraindications to the development of peripheral nerve block
- •- active peptic ulcers or gastrointestinal (GI) bleeding
- •- allergies or intolerances to sufentanil and oxycodone
- •- Allergies or hypersensitivities to amide-type local anesthetics
- •- Allergies or hypersensitivities to the active ingredients of parecoxib and metamizole
- •- Decompensated or inadequately treated heart failure (NYHA III to IV), clinically newly proven coronary artery disease within the last 6 months, peripheral arterial occlusive disease and/or cerebrovascular events within the last 6 months
- •- considerable hypotension and bradycardia as well as severe prostate hyperplasia and biliary tract diseases
- •- Infection at the injection site for regional anesthesia
- •- Cirrhosis of the liver Child-Pugh Grade B and C
- •- GFR < 30
- •- pregnant or breastfeeding patients
- •- women capable of giving birth without contraception; all measures with a Pearl index <1 are regarded as reliable contraception, other methods such as natural contraception are regarded as inadequate contraception.
- •- Refusal of aaspiration by the patient
- •- Patients unable to consent
- •- Participation in another drug study
- •- officially and/or legally accomodated persons
研究者
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