EUCTR2007-002769-11-DK进行中（未招募）1 期
THE EFFECT OF GABAPENTIN ON THORACIC EPIDURAL ANALGESIA FOLLOWING THORACOTOMY – A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL - GABATEA
Department of Cardiothoracic and Vascular Surgery0 个研究点目标入组 104 人开始时间: 2009年12月7日最近更新:
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
- 104
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
- •1. Patients scheduled to undergo elective lung resection via thoracotomy on a malignant indication at the Department of Cardithoracic and Vascular Surgery, Aarhus University Hospital, Skejby.
- •2. Age > 18 and < 80 years
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Inability to answer the detailed questionnaire on pain and quality of life
- •Psychiatric disease (ICD-10)
- •Severe renal impairment (se-creatinin > 110 mmol/l)
- •Known allergy to gabapentin, morphine, bupivacaine and / or ibuprofen
- •Standard use of opiod analgesics
- •Treatment with anticonvulsants or tricyclic antidepressants
- •Use of antacids 24 hours before the intake of study medication
- •Contraindicated placement of a thoracic epidural catheter
- •Previous ipsilateral thoracotomy
- •Presence of a chronic pain syndrome
- •Acute pancreatitis
- •A history of past or current alcohol and / or ilegal substance abuse. Using the Danish National Board of Health's recommendations for weekly intake of < 14 drinks/units for women and < 21 drinks/units for men and / or former or current abuse of drugs.
- •A history of gastric or duodenal ulcer
- •Gastrointestinal obstruction
- •Pregnancy
- •Participation in another intervention study
研究者
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