To Evaluate Reduction of Pain in Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo
Wounds, Local Anesthesia
About this trial
This is an interventional supportive care trial for Wounds focused on measuring wound treatment, lidocaine, pain reduction, local anesthetic
Eligibility Criteria
Inclusion Criteria:
- Patient who has accepted and signed the informed consent before the random process.
- Patients with painful wound treatments
- Wounds or sores of any aetiology (vascular insufficiency, diabetics, traumatic, postsurgical...) that implies at minimum dermis or epidermis, it is, II to IV degree in the Spanish Classification of Sores made by the "National Group to Study and Management of Pressure Ulcers and Chronic Wounds" (GNEAUPP).
- Women in fertile age with pregnancy test negative.
- Men and women in fertile age using contraceptive measures
Exclusion Criteria:
- Precedents of allergic reaction to local anesthesics type amides.
- Wounds or sores degree I on the GNEAUPP Classification (without discontinuity of skin).
- Wounds or sores too large (which require more than 40 ml of solution to cover).
- Wounds around the eyes.
- Patients who presents disturbance of cardiac conduction: atrioventricular block (second or third degree) or bifascicular block
- Patients with altered level of consciousness (Glasgow Coma Scale value less than 14)
- Patients following hemodialysis, peritoneal dialysis or continuous hemofiltration treatment.
- Patients suffering moderate or severe hepatic insufficiency.
- Pregnant or lactating women.
- Patients who refuse to participate in the study.
- Patients requiring wounds treatment more than once each day.
Sites / Locations
- Hospital Universitari de Bellvitge
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Lidocaine solution ("A")
Saline solution ("B")
Two sterile gauzes will be dampen with the content of the second syringe (the content of the first syringe is always 20 ml of saline solution and it is the first sterile gauzes administrated always) that will contain 20ml of 0.5% lidocaine dilution when the wound treatment process is assigned to the letter "A". The nurse has a third syringe exactly like this second syringe to apply if necessary (process still painful to the patient).
Two sterile gauzes will be dampen with the content of the second syringe (the content of the first syringe is always 20 ml of saline solution and it is the first sterile gauzes administrated always) that will contain 20ml of saline solution when the wound treatment process is assigned to the letter "B". The nurse has a third syringe exactly like this second syringe to apply if necessary (process still painful to the patient). In this case, the three syringes supplied to the nurse, have saline solution.