Evaluate pain reduction during wound cleaning after previous application of topic solution of lidocaine vs. placebo
Conditions
Interventions
Trade Name: LIDOCAÍNA CLORHIDRATO 5% Fresenius Kabi, Solución inyectable
Product Name: LIDOCAINE
Product Code: LIDO-0,5
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: LIDOCAINE
CAS Numbe
Sponsors
Dra. Antònia Dalmau i Llitjós. Servicio de Anestesia, Reanimación y Terapéutica del Dolor del HUB-Idibell
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: demonstrate that the application of lidocaine foams prior to wound cleaning, reduces pain of the procedure, compared to the cleaning done after application of saline; with quantified by the reduced value as Verbal Numerical Scale (EVN) with a range of 0 to 10.;Secondary Objective: ? Determine whether the application of lidocaine foams reduces the need to administer rescue doses of systemic analgesics required for cure. ? Determine if it reduces the daily need for rescue analgesia ? To determine what proportion of patients require two applications to study drug ? To assess the safety of treatment with lidocaine vs. placebo: adverse effects.;Primary end point(s): Effectivity as differential between EVN score (0-10), by applying gauze wetted with the content of the preparation number one (always contain physiological saline) vs. applying gauze wetted with the content of the second preparation (study drug: lidocaine or placebo, depending on randomization).;Timepoint(s) of evaluation of this end point: the value of the EVN scale after each cure will be obtained. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Differential between EVN score (0-10), by applying gauze wetted with the content of the preparation number one (always contain physiological saline) vs. applying gauze wetted with the content of the third preparation (study drug: lidocaine or placebo, always containing the same drug preparation number two), if the patient has needed this third application for persistent pain (EVN> 3 during healing after application of the second preparation). b) Reduction of the need of rescue analgesia during cure. c) Reduction of the need of rescue analgesia required daily d) Number of patients who required two applications of treatment (preparation two and three) for pain control. e) Changes in clinical and laboratory values safety related: -Local complications secondary to the application of lidocaine or placebo -Complications secondary to systemic absorption of local anesthetic (neurological, cardiovascular, respiratory or otherwise) -If any symptoms of systemic disturbance appear, we would conduct the appropriate complementary examinations, including determination of methemoglobinemia.;Timepoint(s) of evaluation of this end point: the secondary end points will be evaluated after each cure | — |
Countries
Spain
Contacts
Public ContactServicio de Anestesia
Hospital Universitari Bellvitge-Idibell
Outcome results
None listed