Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration: a Prospective, Randomised, Observer-blind Study in Adult Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sintetica SA
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Time to Regression of Spinal Block
研究概览
简要总结
This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower limb. Patients undergoing elective short-duration lower limb surgery will be randomised into 3 treatment groups (15 patients per group) to receive one of the 3 single doses of Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.
详细描述
To evaluate the efficacy of the three Chloroprocaine HCl 1% doses (i.e. D1, D2 and D3) in terms of time to complete regression of spinal block (i.e. end of anaesthesia)
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex, age and surgery: male/female patients, 18-65 years old, scheduled for short duration (less than 40 min) lower limb surgery requiring ≥ T12 metameric level of sensory block
- •Body Mass Index (BMI): 18 - 32 kg/m2 inclusive
- •ASA physical status: I-II
- •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 spinal anaesthesia. History of neuromuscular diseases to the lower extremities
- •ASA physical status: III-V
- •Further anaesthesia: patients expected to require further anaesthesia
- •Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the ester type and major 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 and neurological diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid disease, diabetes or other neuropathies.
- •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
- •Blood donation: blood donations in the 3 months before this study
- •Pregnancy and lactation: missing or positive pregnancy test at screening, pregnant or lactating women
- •Chronic pain syndromes: patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents or chronic analgesic therapy)
- •Medications: medication known to interfere with the extent of spinal blocks for 2 weeks before the start of the study. Hormonal contraceptives for females are allowed.
研究组 & 干预措施
3 mL Chloroprocaine HCl 1%
Patients in D1 group will receive a single dose of 3 mL Chloroprocaine HCl 1% (corresponding to 30 mg chloroprocaine HCl)
干预措施: Chloroprocaine HCl 1% (Drug)
4 mL Chloroprocaine HCl 1%
Patients in D2 group will receive a single dose of 4 mL Chloroprocaine HCl 1% (corresponding to 40 mg chloroprocaine HCl)
干预措施: Chloroprocaine HCl 1% (Drug)
5 mL Chloroprocaine HCl 1%
Patients in D3 group will receive a single dose of 5 mL Chloroprocaine HCl 1% (corresponding to 50 mg chloroprocaine HCl)
干预措施: Chloroprocaine HCl 1% (Drug)
结局指标
主要结局
Time to Regression of Spinal Block
时间窗: Up to 5 hours after regression of two dermatomers
When Bromage score returns to 0 and sensitive perception returns to S1 To evaluate the efficacy of the three Chloroprocaine HCI 1% doses (i.e. 30 mg, 40 mg e 50 mg) in terms of time to complete regression of spinal block (i.e. end of anaesthesia) Bromage Score is comprised between 1 and 4 (1 equals Free movement of legs and feet while 4 stands for Unable to move legs or feet)
次要结局
- Time to Eligibility for Home Discharge(Expected up to 24 hrs post surgery)
- Excretion of 2-chloro-4-aminobenzoic Acid (CABA) in Urine(at the time of first urine voiding post surgery)
- SpO2(Expected up to 24 hrs post surgery)
- Time to Readiness for Surgery(Up to 40 min after spinal injection)
- Time to Administration of Rescue Anaesthesia or Rescue Analgesia(Expected up to 24 hrs post surgery)
- Concentration of 2-chloro-4-aminobenzoic Acid (CABA) in Plasma(at pre-dose, 5, 10, 30 and 60 min after spinal puncture)
- Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)(Up to 40 min after spinal injection)
- Time to Onset of Motor Block(Up to 40 min after spinal injection)
- Time to Resolution of Sensory Block to S1(Min)(Up to 5 h after regression of two dermatomers)
- Time to Resolution of Motor Block(Up to 5 h after regression of two dermatomers)
- Sensory Block Metameric Level(Up to 5 h after regression of two dermatomers)
- Time to First Post-operative Analgesia(Expected up to 24 hrs post surgery)
- Time to Regression of Spinal Block(Up to 1 h and 40 min after readiness for surgery)
- Time to Unassisted Ambulation(Up to 5 h after regression of two dermatomers)
- Maximum Level of Sensory Block(Up to 1 h and 40 min after readiness for surgery)
- Time to Regression of Two Dermatomers With Respect to the Maximum Level of Sensory Block(Up to 5 h after regression of two dermatomers)
- Time to Maximum Level of Sensory Block(Up to 1 h and 40 min after readiness for surgery)
- Time to First Spontaneous Urine Voiding(Expected up to 24 hrs post surgery)
- Treatment-emergent Adverse Events (TEAEs)(Up to Day 6 +/- 1 after spinal puncture)
- Transient Neurological Symptoms (TNS)(Up to Day 6 +/- 1 after spinal puncture)
- Pain Assessment at the Site of Injection and at the Site of Surgery(Up to Day 6 +/- 1 after spinal puncture)
- Heart Rate(Expected up to 24 hrs post surgery)
- Blood Pressure(Expected up to 24 hrs post surgery)