Painless Local Anaesthesia With Bicarbonate Admixture: A Phase II, Monocentric, Double-blind, Randomized, Placebo-controlled Crossover Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Rating of injection pain between IMP1 and IMP2
研究概览
简要总结
This study examines whether the injection of local anesthesia mixed with sodium bicarbonate in the ratio of 3:1 creates a less burning sensation and is as effective regarding the anesthetic effect as in the ratio of 9:1.
详细描述
Therefore the investigators compare two groups with 24 healthy individuals in each group in a cross-over study. One group receives four injections (two in each forearm) and one group receives only two injections (one in each forearm)
The four injections of group 1 are:
- IMP1: Lidocaine and sodium bicarbonate ratio 3:1
- IMP 2: Lidocaine and sodium bicarbonate ratio 9:1
- IMP 3: Lidocaine
- IMP 4: Sodium cloride 0.9% (=placebo)
The two injections of group 2 are IMP1 and IMP2.
After each injection the individual has to rate their pain sensation on a NRS scale and afterwards the anesthetic effect gets tested by a standardized laser application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy male or female individuals between 18 and 75 years
- •able to understand and speak German
- •able to follow the instructions
- •Exclusion criteria:
- •oversensitivity to lidocaine or other local anesthetics of amide type or sulfites
- •prone to bleeding, intake of aspirine or anticoagulation
- •pregnancy
- •skin on forearms with lesions (i.e. sunburn, wounds, eczema or other skin diseases)
- •previous participation at the same study
排除标准
- 未提供
研究组 & 干预措施
Group 1
Consisting of 24 individuals between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine.
Intervention: Every individual receives four injections IMP1: Lidocaine and sodium bicarbonate ratio 3:1, IMP 2: Lidocaine and sodium bicarbonate ratio 9:1, IMP 3: Lidocaine, and IMP 4: Sodium cloride 0.9% (=placebo), namely two in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the four areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes.
干预措施: Lidocaine and sodium bicarbonate (Drug)
Group 1
Consisting of 24 individuals between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine.
Intervention: Every individual receives four injections IMP1: Lidocaine and sodium bicarbonate ratio 3:1, IMP 2: Lidocaine and sodium bicarbonate ratio 9:1, IMP 3: Lidocaine, and IMP 4: Sodium cloride 0.9% (=placebo), namely two in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the four areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes.
干预措施: Lidocaine (Drug)
Group 1
Consisting of 24 individuals between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine.
Intervention: Every individual receives four injections IMP1: Lidocaine and sodium bicarbonate ratio 3:1, IMP 2: Lidocaine and sodium bicarbonate ratio 9:1, IMP 3: Lidocaine, and IMP 4: Sodium cloride 0.9% (=placebo), namely two in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the four areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes.
干预措施: Sodium cloride 0.9% (Drug)
Group 2
Consisting of 24 different individuals than those belonging to Group 1. Between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine.
Intervention: Every individual receives two injections:
IMP 3 Lidocaine, and IMP 4 Sodium cloride 0.9% (=placebo), namely one in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the two areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes.
干预措施: Lidocaine (Drug)
Group 2
Consisting of 24 different individuals than those belonging to Group 1. Between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine.
Intervention: Every individual receives two injections:
IMP 3 Lidocaine, and IMP 4 Sodium cloride 0.9% (=placebo), namely one in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the two areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes.
干预措施: Sodium cloride 0.9% (Drug)
结局指标
主要结局
Rating of injection pain between IMP1 and IMP2
时间窗: 1 minute
on NRS scale
次要结局
- rating of injection pain of IMP3 and IMP4(1 minute)
- rating of clinical relevance of the difference between pain sensation of the injections(5 minutes)
- assessment of local anesthesia of each injection with a standardized laser(90 minutes)
- duration of anesthetic effect of each injection(maximum 90 minutes)