Comparative Study of Non-inferiority Between Heavy Levobupivacaine With Enantiomeric Excess of 50% (Bupivacaine S75: R25) and Heavy Racemic Bupivacaine (Bupivacaine S50: R50) in Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time of latency for sensory block at T10 dermatome.
研究概览
简要总结
The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.
详细描述
The Heavy Levobupivacaine with Enantiomeric Excess of 50% was developed to be a safe local anesthetic replacing the Heavy Racemic Bupivacaine.
This study will evaluate the non-inferiority regarding efficacy and safety of spinal anesthesia in orthopedic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •ASA (American Society of Anesthesiologists) I or ASA II
- •Spinal Anaesthesia for lower limb surgery
- •Patient Consent
排除标准
- •relative or absolute contraindications for spinal anesthesia
- •history of hypersensitivity to the local anesthetics or components
- •opioids for anesthetic adjuvant
- •spinal lesions, peripheral neuropathies or any other neurologic disorders that leads to changes of sensitivity
- •Body mass index = or > 35
- •lumbar puncture difficulty
- •ventricular extrasystoles
- •dementia, others loss of cognitive ability
- •difficulty in the spine
- •spinal cord surgery
- •anaphylactic reactions or Stevens-johnson Syndrome
- •polytraumatism
- •alcoholism abuse and use of illicit substance
- •Changes in the blood test
- •Others conditions judged by investigator's opinion
研究组 & 干预措施
bupivacaine S75:R25
3 ml for subarachnoid block
干预措施: Bupivacaine (Drug)
bupivacaine (S50:R50)
3 ml subarachnoid block
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Time of latency for sensory block at T10 dermatome.
时间窗: +/- 40 min after injection
Evaluate the sensory block at T10 after the anesthetic injection through sensory stimulation by needle.
次要结局
- Motor Block Evaluation(+/- 30 min)
- Maximum cranial dispersion verifying the largest metamer achieved.(+/- 45 min)
- Time of regression of motor block by Bromage Scale(+/- 9 - 10 hours)
- Evaluation of the cardiocirculatory and respiratory parameters(+/- 8 hours)
- Sensory block duration(+/- 3 hours)
- The residual analgesic effect(+/- 9-10 hours)
- Anesthetic failure(+/- 45 min)
- Adverse Events(+/- 8 - 12 hours)