CTIS2023-505860-12-00进行中（未招募）1 期
Efficacy of perioperative duloxetine in patients at high risk for developing chronic postsurgical pain after inguinal hernia repair: a multicenter randomized controlled trial - ICI21/00006l
Parc De Salut Mar0 个研究点目标入组 294 人开始时间: 2023年6月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 294
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 65+（—）
- 性别
- All
入选标准
- •Men that live in Spain during the entire trial and who are scheduled for open inguinal hernia repair (inpatient or outpatient procedures)., Risk of post-surgical pain chronification = 27% using the GENDOLCAT risk scale.
排除标准
- •Age under 18 years, History of liver failure (Child-Pug B or C), Currently taking a monoamine oxidase inhibitor or other medication with substantial interaction with duloxetine, Antidepressant use within 4 weeks of study start, Treatment with inhibitors of CYP1A2: fluvoxamine, ciprofloxacin or enoxacin, History of uncontrolled hypertension, History of bipolar disorder, History of seizures over 18 years of age, not during chilhood for febrile seizures, Clinical record of acute glaucoma, Treatment with selective serotonin reuptake inhibitors (SSRIs), Treatment with serotonin and noradrenaline reuptake inhibitors (SNRIs), Patients who in the recruiter’s opinion have insufficient knowledge of Spanish to understand the trial, Treatment with tricyclic antidepressants, Treatment with triptans, Treatment with antipsychotic drugs, Treatment with dopamine antagonists, Treatment with oral anticoagulant agents, Treatment with St. John's Wort (Hypericum perforatum), History of Major depression disorder, History of Generalized anxiety disorder, Patients who are currently being treated with duloxetine, Patients with known allergy to duloxetine or hypersensitivity to any of the excipients, Serious renal failure (creatinine clearance >30 ml/min in blood test during 3 months before surgery), Patients requiring reoperation because of surgical complications, Transplanted patients, History of coronary artery disease, including previous myocardial infarction, angina, percutaneous transluminal coronary angioplasty, History of congestive heart failure
研究者
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