Efficacy of Alkalinised 2% Mepivacaine for Local Infiltration Anesthesia, in Ambulatory Phlebectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain Assessment
研究概览
简要总结
The purpose of this study is to assess if a dilution with 1.4% sodium bicarbonate of a 2% mepivacaine+epinephrine solution, can be effective in reducing the pain associated with local infiltration anesthesia, during ambulatory phlebectomy procedures.
详细描述
The use of local anesthesia by infiltration (LIA), usually prepared with 1% lidocaine or mepivacaine 2%, in combination with epinephrine and diluted with saline solution, it's commonly performed in ambulatory phlebectomy procedures.
Although this kind of anesthesia is among the most effective and safe available, the infiltration of local anesthetic is accompanied by pain in the majority of patients. This can be particularly important in ambulatory phlebectomy procedures, where large areas need to be anesthetized.
Numerous methods have been proposed to alleviate the pain associated with LIA, such as reducing the rate of administration or warming the anesthetic solution.
Sodium bicarbonate added in small concentrations, can also be effective in reducing significantly the pain associated with LIA. A recent trial has confirmed the viability and effectiveness of a solution of lidocaine 1% diluted in sodium bicarbonate 1.4%, in varicose vein surgery.
The purpose of this study is to evaluate the effectiveness in alleviating the pain associated with LIA, of a solution of mepivacaine 2%+epinephrine diluted with sodium bicarbonate 1.4%, compared with an analogous solution diluted with normal saline.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing ambulatory phlebectomy
排除标准
- •Allergy to amide anesthetics
- •Sinoatrial node disease or any degree of atrio-ventricular block
- •Acute diseases
- •Chronic kidney or liver disease
- •Treatment with drugs that alter pain sensitivity (e.g. analgesics)
- •Treatment with monoamine oxidase inhibitors or tricyclic antidepressants
- •Major psychiatric disorders according to DSM IV-TR diagnostic criteria
- •Alcohol abuse actual or recent as described in DSM IV-TR
研究组 & 干预措施
Alkalinised anesthetic solution
干预措施: Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4% (Drug)
Non alkalinised anesthetic solution
干预措施: Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9% (Drug)
结局指标
主要结局
Pain Assessment
时间窗: Initial 2 minutes of the procedure
Pain severity will be rated by the subjects on a visual analog scale, after the first five injections (placement of the needle + administration of anesthetic solution).
次要结局
未报告次要终点
研究者
Raffaele Antonelli Incalzi
Professor
Campus Bio-Medico University