Assesing topical analgesia during painful cures.

Randomised, Double-blind Clinical Trial to Evaluate the Reduction of Pain in the Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo in an outpatient.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002352-91-ES

Enrollment

Registered

2018-02-08

Start date

2018-07-10

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluate pain reduction during wound cleaning after previous application of topic solution of lidocaine vs. placebo

Interventions

Trade Name: Lidocaina B.Braun 5% solución inyectable Product Name: Lidocaína B. Braun 50 mg/ml solución inyectable Pharmaceutical Form: Cutaneous solution INN or Proposed INN: lidocaina CAS Number: 13

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 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46

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 20 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: - To assess the safety of treatment with lidocaine vs. placebo: adverse effects. - Evaluate if there are differences in the pain score between 5 minutes after the end of the cure, between the cure performed without foments vs the cure performed after applying the study solution foments (Lidocaine or Placebo, as appropriate by randomization) - Approximate if the time of application, respecting an interval between 7 and 15 minutes, influences the decrease of pain. - Evaluate if the use of foams during the cure, reduces the pain to the 24 hours following the cure;Primary end point(s): Differential to score in the EVN (0-10), between the first cure performed without foams vs the cure performed after applying the study solution fomentations (lidocaine or placebo, as appropriate by randomization).;Timepoint(s) of evaluation of this end point: The value of the EVN scale after each cure will be obtained.	—

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: - To assess the safety of treatment with lidocaine vs. placebo: adverse effects. - Evaluate if there are differences in the pain score between 5 minutes after the end of the cure, between the cure performed without foments vs the cure performed after applying the study solution foments (Lidocaine or Placebo, as appropriate by randomization) - Approximate if the time of application, respecting an interval between 7 and 15 minutes, influences the decrease of pain. - Evaluate if the use of foams during the cure, reduces the pain to the 24 hours following the cure;Primary end point(s): Differential to score in the EVN (0-10), between the first cure performed without foams vs the cure performed after applying the study solution fomentations (lidocaine or placebo, as appropriate by 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): 1. Differential score in the EVN (0-10) at 15 minutes after the end of the cure, between the cure performed without foments vs the cure performed after applying the study solution foments (lidocaine or placebo, as applicable by randomization ). 2. Approximate if the time of application, respecting an interval of between 7 and 15 minutes, influences the decrease of pain. 3.Differential score 24 hours after the cure, between the two cures (no foments vs foments) 4. Clinical monitoring of the occurrence of adverse effects: 4.1. Local complications secondary to the application of lidocaine or placebo 4.2. Systemic complications secondary to absorption of local anesthetic (neurological, cardiovascular, respiratory or other abnormalities) If any symptoms of systemic alteration appear, we would perform an ECG and, if necessary, determine methemoglobinemia. In case of any systemic adverse effects, the anesthesic medical doctor would accompany the patient to the emergency room.;Timepoint(s) of evaluation of this end point: The secondary end points will be evaluated after each cure and after 24 hours the investigator team will do a follow telephone call visit	—

Measure

Time frame

Secondary end point(s): 1. Differential score in the EVN (0-10) at 15 minutes after the end of the cure, between the cure performed without foments vs the cure performed after applying the study solution foments (lidocaine or placebo, as applicable by randomization ). 2. Approximate if the time of application, respecting an interval of between 7 and 15 minutes, influences the decrease of pain. 3.Differential score 24 hours after the cure, between the two cures (no foments vs foments) 4. Clinical monitoring of the occurrence of adverse effects: 4.1. Local complications secondary to the application of lidocaine or placebo 4.2. Systemic complications secondary to absorption of local anesthetic (neurological, cardiovascular, respiratory or other abnormalities) If any symptoms of systemic alteration appear, we would perform an ECG and, if necessary, determine methemoglobinemia. In case of any systemic adverse effects, the anesthesic medical doctor would accompany the patient to the emergency room.;Timepoint(s) of evaluation of this end point: The secondary end points will be evaluated after each cure and after 24 hours the investigator team will do a follow telephone call visit

—

Countries

Spain

Contacts

Public ContactServicio de Anestesia,Reanimación y

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

mdalmau@bellvitgehospital.cat34932607323

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026