Comparative Experimental Study Between Bupivacaine and Ropivacaine Regarding Efficacy in Third Molar Removal Surgery Under General Anesthesia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Evaluate if there is a significant difference between groups in postoperative analgesic capacity using Visual Analog Scale, intraoperative hemostasis and in vital signs during anesthesia.
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of bupivacaine and ropivacaine in third molar removal surgery under general anesthesia in healthy volunteers. The main question aims to determine whether there is any difference in vital signs, hemostasis and postoperative pain between ropivacaine and bupivacaine in patients undergoing third molars extraction under general anesthesia.
Researchers will compare bupivacaine and ropivacaine in a split-mouth study to determine if one drug is more effective in third molar extraction surgery under general anesthesia (better hemostasis, less postoperative pain, and fewer changes in vital signs). Participants will undergo a single surgical procedure and complete the Visual Analog Scale to record postoperative pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 to 60
- •Patients ASA Physical Status Classification I and II
- •Patients with impacted or semi-impacted lower third molars with similar positioning on both sides according to the Pell and Gregory classification
排除标准
- •Patients who can have surgery under local anesthesia
- •Patients where more procedures are required in the same surgical session
研究组 & 干预措施
Group A - Bupivacaine
use of bupivacaine 0,5% + epinephrine 0,2mL in third molar surgery in general anesthesia
干预措施: Bupivacaine 0,5% (Drug)
Group B - Ropivacaine
use of ropivacaine 0,75% + epinephrine 0,2mL in third molar surgery in general anesthesia
干预措施: Ropivacaine 0,75% (Drug)
结局指标
主要结局
Evaluate if there is a significant difference between groups in postoperative analgesic capacity using Visual Analog Scale, intraoperative hemostasis and in vital signs during anesthesia.
时间窗: From surgery to 7 postoperative days
The Visual Analog Scale (0-10 VAS) can be interpreted as no pain (0), mild (1-3), moderate (4-6),severe (7-9),or worse pain (10)
次要结局
未报告次要终点
研究者
Henrique Tedesco
Principal Investigator
Federal University of Rio Grande do Sul