Evaluating the Effectiveness of Dermal Analgesia Provided by the Application of Lidocaine and Prilocaine Cream 5% on the Puncture Site of Axillary Blocks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ®
研究概览
简要总结
Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required for a 50% difference with the standard deviation of the control group, a significance level of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35 patients per group.
The expected benefit is the reduction of pain at the skin puncture during the realization of BAX.
Improving professional practice and quality care
研究设计
- 研究类型
- Interventional
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
- •Age ≥ 18 years
- •Hospitalized for upper extremity surgery scheduled
- •Having an axillary block anesthesia.
- •Free subject, without subordination or guardianship
- •Patients undergoing a social security system or benefiting through a third party
- •Informed consent and signed by the patient after clear and honest information on the study
排除标准
- •Age < 18 years
- •Hypersensitivity to lidocaine, prilocaine, to one of the excipients, castor oil and its derivatives
- •Hypersensitivity to local anesthetics of the amide
- •Congenital Methemoglobinemia
- •Porphyrias
- •Glucose-6-phosphate dehydrogenase
- •Hypersensitivity to any component of Dexeryl ®
- •Disorders of atrioventricular conduction requiring permanent pacing not yet realized.
- •Epilepsy uncontrolled by treatment
- •Patients on anticoagulants
- •Skin infection from the puncture site
- •Patients with psychiatric disorders or dementia
- •Cons-indication for infusion Isofundine ®:
- •Severe congestive heart failure
- •oligoanuria
- •Fluid retention
- •hyperkalemia
- •hypercalcemia
- •Metabolic alkalosis
- •Patients not receiving a social security system or not qualifying through a third party
- •People receiving more protection ie minors, persons deprived of liberty by a judicial or administrative decision, guests staying in a hospital or office, adults under legal protection,
- •Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, oophorectomy total )
研究组 & 干预措施
Lidocaine-Prilocaine 5%
干预措施: Lidocaine-Prilocaine 5% (Drug)
Dexeryl
干预措施: DEXERYL (Drug)
结局指标
主要结局
Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ®
The main objective of the study is to compare the VAS (visual analogue scale) between groups of Lidocaine-Prilocaine 5% and Dexeryl ® in pain at the skin puncture for producing a block in patients undergoing axillary to an upper extremity surgery
次要结局
- satisfaction
- evaluation pain
- success