EUCTR2015-004517-24-AT进行中（未招募）1 期
A prospective, open-label, proof-of-concept pilot study of the effects of a single one-hourtarget-controlled remifentanil infusion on pain in 24 patients with persistent postsurgicalpain. - The effects of remifentanil on persistent postsurgical pain
Wilhelminen hospital0 个研究点开始时间: 2016年3月30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
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
- •male or female
- •at least 18 years of age
- •suffering from pain of at least 40 on the NRS (0-100) – pain” being defined as maximum pain or average pain within the past 24 hours reported retrospectively by the patient
- •the chronic pain is a result of an operation – result of an operation” being defined as (I) (a) the patient was pain-free before the operation or (b) the pain problem was unchanged or worsened after the operation as indicated by the patient and (II) the patient answers the question Do you believe the operation is the or one of the causes of your pain” with Yes”
- •the operation took place at minimum three months and at maximum three years ago
- •body mass index between the 15th and 85th percentile
- •able to understand, read, and write German willing and able to give 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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Patients with a known underlying disease causing this postsurgical pain
- •Patients suffering from pain where the site of maximum pain is impossible or difficult to access for QST measurements
- •Patients currently on analgesic or antitussive opioid therapy
- •Patients scheduled for an invasive procedure within the time-frame of the study
- •Patients scheduled for any other treatment for their chronic pain condition
- •Patients graded as ASA (American Society of Anesthesiologists) 4
- •Patients with a contraindication for undergoing general anesthesia
- •Patients suffering from any somatic pain which is stronger than to be treated pain
- •Patients suffering from: unstable hypertension, acute cardiac decompensation, cardiac valve dysfunction, pulmonary hypertension, relevant cardiac conduction disturbance (= second degree AV-block, anamnestic malignant arrhythmia (e.g. ventricular tachycardia, ventricular fibrillation)), bronchial asthma, chronic obstructive pulmonary disease (COPD) >GOLD II
- •Patients suffering from any known severe psychiatric condition
- •Patients with implanted cardiac converter or pacemaker
- •Pregnancy or breast-feeding
- •Known abuse of alcoholic beverages or any illegal drug
- •Known allergy against the interventional medication, against any of the drugs used for induction or maintenance of the anesthesia or against any study assessment devices
- •Currently enrolled in another clinical trial
- •Participation in a clinical trial in the 2 weeks preceding the study (except solely observational/non-interventional trials)
- •Unable or unwilling to give informed consent
- •Unable or unwilling to follow investigator’s instructions
- •Unable or unwilling to comply with study protocol
- •Patients suffering from any known medical conditions which may interact with study medication, study objectives, or compliance of subject with study tasks.
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