UNICENTER RANDOMIZED SIMPLE BLIND CLINICAL TRIAL TO COMPARE THE EFFECTIVENESS OF LIDOCAINE SPRAY VERSUS CONVENTIONAL ANALGESIA WHILE CURES IN PATIENTS WITH COMPLEX SURGICAL WOUNDS

INTERVENTION: Trade Name: LIDOCAINE Pharmaceutical Form: Concentrate for cutaneous spray, emulsion INN or Proposed INN: lidocaina CAS Number: 6108‐05‐0 Other descriptive name: LIDOCAINE HYDROCHLORIDE MONOHYDRATE Concentration unit: g/ml gram(s)/millilitre Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Concentrate and solvent for solution for injection/infusion Route of administration of the placebo: Cutaneous use CONDITION: analyse whether patients with intravenous analgesic treatment will have the same degree of pain that patients with the same pattern of analgesia, they make a topical application of lidocaine 2% during the wound dressing. Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: To analyse whether patients with intravenous analgesic treatment will have the same degree of pain that patients with the same pattern of analgesia, they make a topical application of lidocaine 2% during the wound dressing. Primary end point(s): Decrease the degree of pain at least one point in VAS; practically nonexistent lidocaine plasma relationship, not related to the administration of lidocaine in wound Secondary Objective: Quantify pain perceived by the patient before and after performing the cure.; To analyze the hemodynamic ‐related pain cure has in the two groups; Analyze if stinging / itching while being treated with topical application of lidocaine; Compare the absorption of lidocaine in plasma in both groups; Analyze patient satisfaction Timepoint(s) of evaluation of this end point: To be considered SECONDARY OUTCOME: Secondary end point(s): Qualitatively analyze stinging / itching after administration of lidocaine in wound; Patient satisfaction with lidocaine is at least one point above the patient without lidocaine in wound Timepoint(s) of evaluation of this end point: To be considered INCLUSION CRITERIA: Patients with surgical wounds that meet criteria for complex wound (those wounds where it is better to delay the closure of the wound until the wound good granulation tissue is developed. Written informed consent signed Ability to self‐assess and report their pain level . 18 and over 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8