Study Phase III to Evaluate the Noninferiority of Heavy Levobupivacaine 50% Enantiomeric Excess (Levobupivacaine S75:R25) Compared to Racemic Heavy Bupivacaine (Bupivacaine S50:R50) in Spinal Anesthesia for Lower Limb Orthopedic Procedures
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Duration time of the sensory block of T10.
研究概览
简要总结
Clinical trial phase III, noninferiority, controlled, double-blind, randomized. The purpose of this study is to evaluate the noninferiority between Levobupivacaine and Bupivacaine in spinal anesthesia.
详细描述
Objectives:
Primary:
- Evaluation of latency to sensory block of T10.
- Evaluation of the duration of sensory block.
Secondary:
- Evaluation of the motor block degree.
- Evaluation of motor block duration.
- Evaluation of cardiovascular safety.
- Block failure.
- Observation of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes;
- •Age between 18 and 80 years;
- •Risk anesthetic classified as ASA I or ASA II, according to the American Society of Anesthesiology;
- •What have indication for spinal orthopedic surgery in the lower limbs;
- •Have agreed to participate and signed the informed consent form.
排除标准
- •Absolute or relative contraindications to spinal anesthesia;
- •Hypersensitivity or intolerance to local anesthetics or to components of the formula;
- •Spinal cord injuries, peripheral neuropathy or other neurological condition that lead to sensitivity and/ or motor function disorder;
- •Dementia, mental retardation and others important cognitive changes;
- •Obesity with a body mass index ( BMI ) ≥ 35 or difficulty in executing the puncture;
- •Anatomical column difficulty in the opinion of the investigator;
- •Previous spine surgical intervention;
- •Polytrauma;
- •Tattoo at the puncture site;
- •Alcoholism;
- •Abuse of illicit substances;
- •Antecedents of severe anaphylactic reactions or Steven - Johnson disease;
- •Changes in security checks;
- •Participation in a clinical study in the 12 months preceding this inclusion;
- •Pregnancy and lactation;
- •Any other condition that in the opinion of the investigator, may lead to increased risk for the patient.
研究组 & 干预措施
Levobupivacaine
Presentation: injectable solution - ampoule of Levobupivacaine Hydrochloride
Indication: production of subarachnoid block (spinal/ spinal anesthesia).
干预措施: Levobupivacaine (Drug)
Bupivacaine
Presentation: injectable solution - ampoule of Bupivacaine Hydrochloride
Indication: production of subarachnoid block (spinal/ spinal anesthesia).
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Duration time of the sensory block of T10.
时间窗: 01 day.
Duration of anesthesia as for the sensory aspect through a needle stimulus in the anterior side of the foot.
Time of latency to achieve sensitive block of T10.
时间窗: 01 day.
The interval of time between the withdrawal of the needle at the end of local anesthetic injection and the absence of response to sensory stimulus in the region corresponding to the T10.
次要结局
- Sensory block intensity.(02 days.)
- Motor block duration.(02 days.)
- Adverse events.(02 days.)
- Cardiovascular safety.(02 days.)
- Block failure.(02 days.)