Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Injection pain
研究概览
简要总结
The purpose of this study is to determine the optimal amount of lidocaine buffering needed to decrease injection pain when administering local anesthesia.
详细描述
Once the site is chosen, the skin will be anesthetized as usual. This study will utilize a commercially prepared 1% lidocaine solution mixed with standard sodium bicarbonate. A total of 10 mL will be used.
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
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults presenting for routine thyroid biopsy, paracentesis or thoracentesis in interventional radiology
排除标准
- •Patients requiring sedation
- •Patients with altered mental status
- •Patients allergic to lidocaine or sodium bicarbonate
研究组 & 干预措施
Arm D
5 mg/mL 50% sodium bicarbonate-50% lidocaine Frequency: 1
干预措施: sodium bicarbonate (Drug)
Arm A
10 mg/mL lidocaine; Frequency: 1
干预措施: lidocaine (Drug)
Arm B
9 mg/mL of 10% sodium bicarbonate-90% lidocaine; Frequency: 1
干预措施: lidocaine (Drug)
Arm B
9 mg/mL of 10% sodium bicarbonate-90% lidocaine; Frequency: 1
干预措施: sodium bicarbonate (Drug)
Arm C
7.5 mg/Ml of 25% sodium bicarbonate-75% lidocaine Frequency: 1
干预措施: lidocaine (Drug)
Arm C
7.5 mg/Ml of 25% sodium bicarbonate-75% lidocaine Frequency: 1
干预措施: sodium bicarbonate (Drug)
Arm D
5 mg/mL 50% sodium bicarbonate-50% lidocaine Frequency: 1
干预措施: lidocaine (Drug)
结局指标
主要结局
Injection pain
时间窗: 6 months
numeric pain scale
次要结局
未报告次要终点