EUCTR2015-004227-31-AT进行中（未招募）1 期
Clinical pilot study to review the impact of perioperative administration of the synthetic cannabinoid nabilone in the context of spinal fusion surgery on the coping with surgery and the pain perception of patients with severely reduced quality of life - Cannabinoid-Spinal-Fusion-Study
OA Dr. Philipp Becker c/o Abteilung für Wirbelsäulenchirurgie, Orthopädisches Spital Speising GmbH0 个研究点目标入组 36 人开始时间: 2016年3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
- 36
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
- •Written informed consent
- •Indication for a spinal fusion surgery
- •Suspected availability within the max.120 day period of study participation
- •No identification of any exclusion criterion
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1) Non-completion of the 18th year of life
- •2) Detention (for a court or administrative order), accommodation
- •(under Unterbringungsgesetz) or (already made or in the) appointment
- •of a trustee
- •3) Limited contractual capability
- •4) Military service
- •5) Pregnancy and not excluded pregnancy (women of childbearing
- •6) Risk of the occurrence of pregnancy during the study participation (in
- •women the absence of at least one of the following criteria: onset of
- •menopause more than 2 years ago, postmenopausal sterilization,
- •surgical sterilization, use of a reliable method of contraception for the duration of the study with hormones, intrauterine device (coil) or diaphragm / condom + spermicide)
- •7) Lactation
- •8) HADS-Anxiety> 8
- •9) HADS-Depression> 8
- •10) Treatment with a cannabinoid or consumption of cannabis or analogous substances within the past 6 months
- •11) Contraindication for nabilone
- •12) Start of opioid therapy in the last week
- •13) (except for the investigational drug:) Foreseeable treatment with cannabinoids or consumption of cannabis or analogous substances during study participation
- •14) Absolute contraindication for the use of postoperative medication required to be applied (Mexalen®, Tradolan®, Dipidolor® and Zofran
- •15) Unsatisfactory treatability of pain resulting from multiple contraindications for the use of analgesics and analgesics classes
- •16) Foreseeable compliance problems
- •17) Concomitant disease with the potential for a relevant short-term improvement or worsening of pain and mental state
- •18) Participation in another study with insurance cover
- •19) Running processes for early retirement / long-term sick leave
- •20) (Except for the surgery-related hospitalization:) planned hospital stay within the next four months (incl. stays preceding surgery at other Departments of the Orthopedic Hospital Speising)
研究者
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