Evaluation of the Effects of Articaine and Bupivacaine in Impacted Third Molar Tooth Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Hemodynamic Changes
研究概览
简要总结
Articaine is a common local anesthetic used in oral surgery and belongs to the amide group of it has fast onset with little side effects. Bupivacaine is preferred in prolonged surgical procedures with its long duration of action and residual analgesic effect.
The aim of this study was to evaluate the anesthetic, analgesic, hemodynamic effects of 4% articaine and 0.5% bupivacaine in extraction of impacted mandibular third molar teeth in intraoperative and postoperative periods. Hemodynamic parameters, onset of anesthetic action, total amount, intraoperative comfort, intraoperative bleeding, duration of postoperative anesthesia and analgesia, rescue analgesic use, maximum incisal opening and postoperative pain at 6th, 12th, 24th, 48th and 72th hours and 7th day using a visual analogue scale be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
This was a triple-blinded study in which the surgeon, the patient and the statistician who performed the data analysis did not know which anesthetic solution had been used.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients above 18 years of age with bilaterally symmetric, impacted or partially impacted mandibular third molar and patients classified in American Society of Anesthesiologists (ASA) 1 group.
排除标准
- •Patients with the presence of any systemic diseases, patients allergic to articaine and bupivacaine or any other NSAIDs and patients with analgesic or anti-inflammatory drugs usage in 15 days before to the surgery.
结局指标
主要结局
Hemodynamic Changes
时间窗: 60 minutes
Systolic and diastolic blood pressure, cardiac rate and blood oxygen saturation level were monitored using a patient monitor before beginning of the surgery (T1), 1 min later following the anesthesia (T2) and immediately after the surgery (T3).
Postoperative pain
时间窗: 1 week
Postoperative pain was evaluated by Visual Analogue Scale (VAS) ranging from 0 to 10 and patients were instructed to complete the scale in 6th, 12th, 24th, 48th and 72th hours and 7th day postoperatively.
次要结局
- Operation time(60 minutes)
- Intraoperative bleeding(60 minutes)
- Maximum mouth opening(7days)
- Duration of Surgery(60 minutes)
- Quality of the anesthesia(60 minutes)
- Surgical difficulty(60 minutes)
- Onset of anesthetic action(10 minutes)
- Duration of the postoperative anesthesia(6 hours)
研究者
Fatih Mehmet Coskunses
Associate Proffesor
Kocaeli University