CTIS2023-505263-37-00进行中（未招募）1 期
The effect of the Popliteal Plexus Block on the motor function of the leg - a randomized, controlled, blinded study in volunteers
Region Midtjylland0 个研究点目标入组 40 人开始时间: 2023年4月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Age >= 18 years old, ASA class 1-2 (American Society of Anesthesiologist classification), Ability to give their written informed consent to participating in the study after having fully understood the contents of the study
排除标准
- •Age > 64 years, Subjects diagnosed with epilepsy, neurologic diseases, severe hypoxia or respiratory depression, hypovolemia, shock, bradycardia or Wolff-Parkinson-Whites syndrome, Subjects with a positive pregnancy test (Women < 60 years must demonstrate a negative pregnancy test (25 mIU/ml) prior to inclusion. Pregnancy test is offered at the trial site at the day of treatment. If the woman fulfills one of the following criteria of not being pregnant, a pregnancy test is not required: 1. Menopausal: woman +50 years old and no period for more than 1 year without any other obvious explanation, or if menopause has been confirmed by measuring LH and FSH. 2. Pregnancy is not possible due to use of highly effective birth control, sterilization, living in a homosexual relationship, living in total sexual abstinence, or hysterectomy., Subjects diagnosed with cardiovascular disease or heart failure, Subjects diagnosed with partial or complete cardiac block, Subjects in daily treatment with class III antiarrhythmics (e.g. amiodarone), Subjects in daily treatment with drugs that are structurally related to local analgesics or class IB antiarrhythmics, as the toxic effects are additive, Subjects diagnosed with severe liver disease or reduced kidney function, Subjects who cannot cooperate with the study, Subjects who cannot understand or speak Danish, Subjects with allergy to the medicines used in the study, Subjects suffering from alcohol and/or drug abuse – based on the investigator's opinion, Pathology or previous major surgery to the lower limb, Intake of any analgesics 24 hours prior to baseline measurements, BMI > 35, Active signs of infection in the cutaneous area of injection
研究者
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