Anesthetic Efficacy of 4% Buffered Lidocaine in Emergency Patients With Facial Swelling.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale
研究概览
简要总结
The purpose of this study is to determine the clinical efficacy of a buffered 4% lidocaine solution for incision and drainage. Ninety patients will be examined clinically to determine a diagnosis of cellulitis or fluctuance. The diagnosis will be confirmed by incision and drainage. Patients will receive either 3.6 ml 4% lidocaine with 1:100,000 epinephrine or 3.6 ml 4% lidocaine with 1:100,000 epinephrine buffered with 8.4% sodium bicarbonate. Patients will rate pain prior to and throughout the procedure.
详细描述
Incision and drainage of swellings is painful and anesthetic failure is common. One reason may be related to the lowered pH of inflamed tissue reducing the amount of the base form of anesthetic. A buffered anesthetic solution may result in more effective anesthesia than a non-buffered solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •in good health (ASA classification I or II)
- •able to give informed consent
- •necrotic tooth with associated facial swelling
排除标准
- •allergies to local anesthetics or sulfites
- •history of significant medical problems (ASA classification III or greater)
- •pregnancy
- •inability to give informed consent
结局指标
主要结局
Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale
时间窗: during incision/drainage on Day 0
Patients will rate pain on a Heft-Parker visual analog scale during needle insertion, placement, and solution deposition phases of the anesthetic injection(s). Patients will also rate pain during the incision and dissection phases of the incision and drainage procedure. The number of millimeters along the scale are reported. No pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of "faint", "weak", and "mild pain". Moderate pain was defined as greater than 54 mm and less than 114 mm and included the descriptor "moderate". Severe pain was defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain included the descriptors of "strong", "intense", and "maximum possible."
次要结局
- Postoperative Satisfaction on a 100 mm Visual Analog Scale(immediately post-procedure on Day 0)
研究者
Melissa Drum
Associate Professor
Ohio State University