EUCTR2014-002519-40-AT进行中（未招募）1 期
A prospective, randomised, non-inferiority study of Chloroprocaine 2% and the active control Ropivacaine 0.75% (AstraZeneca) in ultrasound-guided axillary nerve block for short-duration distal upper limb surgery - Chloroprocaine 2% - Axillary block
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 211
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. Sex and surgery: male and female patients scheduled for short duration (< 60 min) distal upper limb surgery under axillary nerve block anaesthesia
- •2. Age: = 18 years old
- •3. Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
- •4. ASA physical status: I-III
- •5. Informed consent: signed written informed consent before inclusion in the study
- •6. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 61
排除标准
- •1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to peripheral nerve block anaesthesia. History of neuromuscular diseases to the upper extremities
- •2. Axillary status: Axillary local infections, surgical scarring and pathological lymph node enlargement
- •3. ASA physical status: IV-V
- •4. Further anaesthesia: Patients anticipated to be requiring further anaesthesia (general or local anaesthesia)
- •5. Chronic pain syndromes: Patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents)
- •6. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics
- •7. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric diseases, sepsis, blood coagulation disorders, insulin dependent diabetes mellitus, terminal kidney failure
- •8. Medications: Medication known to interfere with the extent of regional blocks (see chloroprocaine and ropivacaine SmPCs) for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed
- •9. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study
- •10. Drug, alcohol: history of drug or alcohol abuse
- •11. Pregnancy: missing or positive pregnancy test at screening, pregnant or lactating women
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