Double-Blind Randomized Clinical trial to assess the pain reduction in wound healing with previous application of cutaneous lidocaine solution versus placebo - LIDO

Dra. Antònia Dalmau i Llitjós. Servicio de Anestesia, Reanimación y Terapéutica del Dolor del HUB-Idibell0 个研究点开始时间: 2014年11月4日最近更新: 2015年7月10日

适应症

试验速览

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•a) signed and dated informed consent before randomization process
•b) male or female
•c) older or equal to 18 years
•d) Patients with painful wound care
•e) Wounds or ulcers of any origin (vascular deficit, diabetic, traumatic, postsurgical ...) with skin damaged
•f) Women with a negative result on a pregnancy test.
•g) Men and women of childbearing potential must agree to use effective contraception throughout treatment
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•a) history of allergic reaction to local anesthetics of the amide type.
•b) Wounds or ulcers of grade I (injury seamless skin)
•c) very large wounds (requiring more than 40 ml of solution)
•d) periocular Wounds
•e) Patients with impaired cardiac conduction atrioventricular block of 2nd or 3rd degree heart block or bifascicular
•f) Patients with altered level of consciousness
•g) Patients on hemodialysis, peritoneal dialysis or continuous hemofiltration
•h) Patients with moderate or severe hepatic impairment
•i) Pregnant or breast-feeding.
•j) Patients who refuse to participate

发起方

Dra. Antònia Dalmau i Llitjós. Servicio de Anestesia, Reanimación y Terapéutica del Dolor del HUB-Idibell