NCT01303107撤回3 期
A Non-Inferiority Phase 3 Comparative Study Between a Heavy Levobupivacaine in 50% Enantiomeric Excess (Bupivacaine S75:R25) and Heavy Racemic Bupivacaine for Cesarean Operation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- latency of sensitive block at T6
研究概览
简要总结
The purpose of this study is to determine if the mixture of enantiomers of bupivacaine (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the racemic mixture of enantiomers of bupivacaine (bupivacaine S50:R50).
详细描述
The enantiomeric mixture of bupivacaine S75:R25 (75% levobupivacaine and 25% bupivacaine) was develop to be a safety regional anesthetic in substitution to racemic bupivacaine (S50:R50).
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •parturients at term
- •ASA (American Society of Anesthesiologists) I or ASA II
- •elective cesarean section with low risk labor
- •pre-natal follow-up
- •patient consent
排除标准
- •relative or absolute contraindications for spinal anesthesia
- •history of hypersensitivity to the local anesthetics
- •use of opioids during labor
- •labor lasting more than 12 hours or less than 1 hour
- •complications of pregnancy such as placenta previa, pre-eclampsia or eclampsia; maternal-fetal malnutrition;important accidents during pregnancy.
- •spinal lesions, peripheral neuropathies or any other neurologic disorders that lead to changes of sensitivity and/or motricity
- •decompensated diabetes or hypertension
- •history of alcohol and/or drug abuse
- •cardiopathies, especially myocardiopathies and valvulopathies; important cognitive changes
- •changes in safety exams
- •twin pregnancy;
- •signs of intrauterine distress, and abnormalities of fetal vitality, prematurity
研究组 & 干预措施
bupivacaine S50:R50
Active Comparator
3 ml subarachnoid block
干预措施: Bupivacaine (Drug)
bupivacaine S75:R25
Experimental
3 ml for subarachnoid block
干预措施: Bupivacaine (Drug)
结局指标
主要结局
latency of sensitive block at T6
时间窗: loss of pain in T6
The anesthesiologist will evaluate the loss of pain to pin-prick in T10.
次要结局
- duration of the anesthesia(recovery of the sensibility)
- Degree of motor block(End of motor block)
- maximal level of the sensitive blockade(last level of sensitive blockade)
- Maternal cardiocirculatory and respiratory parameters(During the study)
- Parturients ambulation(regression of the motor blockade)
- Visceral pain(suture of the peritoneum)
- Neonatal repercussions(birth of the neonatal)
研究者
研究点 (2)
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