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临床试验/EUCTR2013-003346-16-ES
EUCTR2013-003346-16-ES进行中(未招募)1 期

Comparative study between continuous perfusion and split doses in the treatment of postoperative pain - Elastomeric pumps versus intravenous split doses in postoperative pain

Hospital Universitari Sagrat cor0 个研究点开始时间: 2015年12月10日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

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

  • - Over 18 years old
  • - Patients with analgesic needs superior to 48 hours and an equivalent minimal in-hospital stay.
  • - Patients undergoing:
  • . Orthopaedic Surgery: hip prosthesis, shoulder pathologies
  • . General Surgery: eventroplasty, anal fissure and cholectomy
  • . Gynecologic Surgery: hysterectomy
  • - Patients providing 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 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 84

排除标准

  • - Non elective surgery
  • - Different analgesic requirements
  • - Patient admission to ICU
  • - Allergy or hypersensitivity to any drug used in the study
  • - Contraindication for any of the study drugs:
  • . Medical history of agranulocytosis and aplastic anemia
  • . Acute intermittent porphyria
  • . Glucose 6 phosphate dehydrogenase deficiency
  • . Digestive haemorrhage, esophageal haemorrhage, active peptic ulcer, cranial haemorrhage.
  • . Respiratory depression
  • . Severe chronic obstructive pulmonary disease
  • - Pregnancy suspicion
  • - Failure or severe hepatic insufficiency: score: Child-Pugh 10-15
  • - Failure or mild-severe renal insufficiency: CICr <50ml/min or creatinine >2mg/dl
  • - Severe emotional depression, dementia and/or mental disorders
  • - Obesity: Body mass index >30 Kg/m2
  • - Refusing to provide informed consent

研究者

发起方
Hospital Universitari Sagrat cor

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