DRKS00017468进行中(未招募)2 期
A randomized, open, three-arm comparative study of modern methods of postoperative pain therapy in patients with knee endoprostheses - SchmerzKEP
Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät0 个研究点目标入组 85 人开始时间: 2019年10月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •Indication for implantation of a unilateral knee endoprosthesis
- •- Patients with (American Society of Anesthesiologists) ASA Score 1 to 3
- •- Signed informed consent
排除标准
- •- other endoprosthesis on a lower extremity (NRS>4)
- •- Patients with a previous spinal surgery
- •- permanent intake of opioids WHO stage III (more than 6 weeks before the planned surgery)
- •- clinically relevant Obstructive Sleep Apnea Syndrome
- •- clinically relevant COPD
- •- Cor pulmonale
- •- severe bronchial asthma, severe coagulation disorders or other contraindications to the development of peripheral nerve block
- •- allergies or intolerances to sufentanil and oxycodone
- •- Allergies or hypersensitivities to amide-type local anesthetics
- •- 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.
- •- Patients unable to consent
- •- Participation in another drug study
- •- officially and/or legally accomodated persons
研究者
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