NL-OMON41519已完成3 期
Effect of pre-operative pain treatment by means of duloxetine on postoperative outcome after total hip or knee arthroplasty - Duloxetine in OsteoArthritis study (DOA-study)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 119
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Primary hip/knee osteoarthritis (based on clinical and radiological ACR-criteria)
- •2. Age >18 years
- •3. A neuropathic or at least a mixed neuropathic / nociceptive pain phenotype (m-painDETECT-score >12)
排除标准
- •General exclusion criteria:
- •1. Surgical hip or knee joint procedures less than 1 year previously
- •2. Cognitive and/or neurological disorders that could interfere strongly with questionnaire surveys (e.g. Dementia)
- •3. Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation.
- •4. Planned or intended to perform THA or TKA within the study duration (present planned arthroplasty not included)
- •5. A history of peripheral nerve injury
- •6. Previous exposure to Duloxetine;Duloxetine related exclusion criteria:
- •7. Allergy to study medication or compounds of the Duloxetine capsule (or another SNRI);
- •8. History of peptic ulcer disease or bleeding disorder (or other substantial risk factor for bleeding)
- •9. Psychiatric disorders, other than depression;
- •10. Severe depression (HADS score >15 on depression subscale);
- •11. A history of alcohol or other substance abuse (excluding nicotine and caffeine) or dependence within the five years prior to enrollment;
- •12. Currently pregnant or lactating, our planned to become pregnant within the study period
- •13. History of cardiac arrhythmias, cardiac failure, myocardial infarct;
- •14. impaired function of the liver, or known cirrhosis or liver transplantation;
- •15. severe renal impairment, or had renal transplantation or receiving renal dialysis;
- •16. Hyponatraemia, or a history of frequent hyponatremias;
- •17. History of uncontrolled hypertension, history of glaucoma (or with increased intraocular pressure) ,uncontrolled thyroid disease and a history of uncontrolled seizures;
- •18. Usage of non selective monoamine oxidase (MAO) inhibitors, TCA*s , SSRIs, SNRIs in the last year;
- •19. Usage of strong CYP1A2-inhibitors
研究者
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