EUCTR2015-003208-22-AT进行中（未招募）1 期
Does a two-day pretreatment with capsaicin reduce postoperative hyperalgesia and pain in surgical patientsA prospective, randomized, double-blind, placebo-controlled, parallel group, single-center clinical trial on the effects of preoperative capsaicin-induced TRPV1-fiber desensitization on postoperative LTP-like pain plasticity in surgical patients - CaPsaPPP
Wilhelminen hospital0 个研究点开始时间: 2015年10月1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
- •male or female, at least 18 years of age
- •planned elective surgery requiring incision of the abdominal wall
- •currently pain free or suffering from spontaneous pain in the last 24 hours of less than 4 on the numeric rating scale in the area of planned surgery
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •patients undergoing scheduled surgery with less than 3 full days until surgery date
- •patients undergoing surgery with planned local anesthetic procedures (peripheral nerve block, , epidural or spinal anesthesia) or planned use of NMDA-receptor antagonists (i.e. ketamine i.v. or p.o.)
- •patients scheduled for postoperative controlled respiratory treatment at the intensive care unit (ICU)
- •patients under the age of 18
- •patients suffering from acute or chronic pain with an intensity of greater than 3 on the numeric rating scale (spontaneous within the last 24 hours)
- •patients currently on prescribed regular analgesic medication
- •patients suffering from any known psychiatric condition
- •patients suffering from unstable hypertension
- •patients with implanted cardiac converter or pacemaker
- •pregnancy or breast-feeding
- •known abuse of alcoholic beverages or any illegal drug
- •known allergy against interventional or placebo medication, patch contents or study assessment devices
- •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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