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
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