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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sintetica SA
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Successful Block for Distal Upper Limb Surgeries
研究概览
简要总结
The Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for distal upper limb surgeries Successful block: anaesthesia adequate for the surgery without any supplementation in the first 45 min.
详细描述
This Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for distal upper limb surgeries, without any supplementation in the first 45 min (see definitions below), calculated from the time of readiness for surgery (complete sensory block). Successful block: anaesthesia adequate for the surgery (complete sensory block), without any supplementation in the first 45 min (even if surgery lasts for > 45 min), calculated from the time of readiness for surgery (complete sensory block). Supplementation: i.v. premedication or general anaesthesia or pre- or intra-operative systemic analgesia or additional local anaesthetic infiltration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex and surgery: male and female patients scheduled for short duration (< 60 min) distal upper limb surgery under axillary nerve block anaesthesia
- •Age: ≥ 18 years old
- •Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
- •ASA physical status: I-III
- •Informed consent: signed written informed consent before inclusion in the study
- •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
排除标准
- •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
- •Axillary status: Axillary local infections, surgical scarring and pathological lymph node enlargement
- •ASA physical status: IV-V
- •Further anaesthesia: Patients anticipated to be requiring further anaesthesia (general or local anaesthesia)
- •Chronic pain syndromes: Patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents)
- •Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics
- •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
- •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
- •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
- •Drug, alcohol: history of drug or alcohol abuse
- •Pregnancy: missing or positive pregnancy test at screening, pregnant or lactating women
研究组 & 干预措施
Chloroprocaine HCl 2% (20 mg/mL)
Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
干预措施: Chloroprocaine HCl 2% (Drug)
Ropivacaine 0.75% (7.5 mg/mL)
Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
干预措施: Ropivacaine 0.75% (Drug)
结局指标
主要结局
Percentage of Participants With Successful Block for Distal Upper Limb Surgeries
时间窗: 45 min from the time of readiness of surgery
Percentage of patients with a successful block for distal upper limb surgeries, without any supplementation in the first 45 min, calculated from the time of readiness for surgery (complete sensory block).
次要结局
- Time to Regression of Sensory Block(Up to 12 hrs after surgery)
- Neurological Symptoms(from surgery day to day 6 +/- 1 after surgery)
- Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)(Up to 1 h after last perineural injection)
- Time to Onset of Motor Block(Up to 1 h after last perineural injection)
- Time to Regression of Motor Block(Up to 12 hrs after surgery)
- Partecipants Received Rescue Anaesthesia or Rescue Analgesia(45 min from the time of readiness of surgery)
- Number of Subjects Who Received Post-operative Analgesia(From surgery day to 24 hrs post surgery)
- Time to Eligibility for Home Discharge(from surgery day to 24h post surgery)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(from surgery day to day 6 +/- 1 after surgery)
- Heart Rate(from surgery day to 24 hrs post surgery)
- Blood Pressure(from surgery day to 24 hrs post surgery)
- SpO2(from surgery day to 24 hrs post surgery)
- Number of Participants With Normal Electrocardiogram (ECG) Parameters(from surgery day to 24 hrs post surgery)