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临床试验/EUCTR2019-001502-23-ES
EUCTR2019-001502-23-ES进行中(未招募)1 期

Randomized, open and controlled clinical trial to evaluate pain after elective open surgery of the liver and pancreas in patients treated with spinal anesthesia with morphine chloride. On-Q incisional catheters.

Rafael Uña0 个研究点目标入组 60 人开始时间: 2019年7月4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
入组人数
60

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

入选标准

  • - Age between 18 and 75 years
  • - Hepatic or pancreatic pathology that is going to be operated through open scheduled surgery at the La Paz university hospital (hepatic resection or pancreatic resection with Whipple type reconstruction).
  • - Sign 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 60
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • ? Patients allergic to local anesthetics.
  • ? Patients classified as ASA IV.
  • ? Patients diagnosed with mental retardation (communicative disability with the researcher).
  • ? Technical impossibility to carry out spinal anesthesia (scoliosis, postsurgical manipulation of the lumbar spine and / or lipoma).
  • ? Patients previously operated on for open surgery by midline laparotomy.
  • ? Personal history of chronic use (more than 1 month) of opioids.
  • ? Patients with chronic renal failure (estimated glomerular filtration rate less than 60 ml / min / 1.73 m2 and / or creatinine greater than 1.5 mg / dl.
  • ? Patients diagnosed with epilepsy (treated with antiepileptic drugs for more than 1 year).
  • ? Patients with hepatic impairment (Child B Classification and / or C in the last month).
  • ? Patients with morbid obesity (BMI greater than 39).
  • ? Patients diagnosed with obstructive sleep apnea syndrome who are being treated with nocturnal CPAP.
  • ? Patients who according to the investigator's criteria will not be able to perform the study procedures.

研究者

发起方
Rafael Uña

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