Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block
试验速览
- 阶段
- 4 期
- 入组人数
- 48
- 主要终点
- Cardiovascular safety
研究概览
简要总结
The purpose of this study is to determine if bupivacaine (75% levobupivacaine plus 25% racemic bupivacaine) with vasoconstrictor is effective and safety as ropivacaine in brachial plexus block for orthopedic surgery.
详细描述
The intoxication by Bupivacaine is considered life threatening. Currently the most safety local anesthetic in substitution to bupivacaine is ropivacaine, however in Brasil there is a bupivacaine mixture of 75% levobupivacaine plus 25% racemic bupivacaine. The research design is:
Patients involved: 48; age: 18 to 40 years old; both sex; ASA I and II. Surgery: elective upper extremity orthopedic surgery. Anesthesia technique: brachial plexus block. Primary endpoint: cardiovascular safety; analysis by continuous Holter. Secondary endpoint: anesthetic and analgesic efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients involved: 48; ASA I and II;
- •Surgery: elective upper extremity orthopedic surgery.
排除标准
- •Contraindications to anesthesia technique and/or to local anesthetic;
- •Participation in different trials in the last two months;
- •Antiretroviral users;
研究组 & 干预措施
B
Arm number B corresponds to the Bupivacaine group.
干预措施: Bupivacaine (Drug)
R
Arm number R corresponds to the Ropivacaine group.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Cardiovascular safety
时间窗: Two days
次要结局
- Anesthesia Analgesia quality(Two days)