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.
Conditions
Interventions
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
Co
Sponsors
Diana Molina Villaverde
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Pregnancy. severe liver or renal dysfunction diagnosed. Participation in other clinical trials History of allergy to sulfur, lidocaine or mepivacaine, NSAIDs, or other local anesthetics and banana or derivatives open fractures , burns, traumatic wounds, pressure ulcers, venous ulcers, arterial ulcers , diabetic ulcers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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;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;Timepoint(s) of evaluation of this end point: To be considered | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactDiana Molina
Diana Molina Villaverde
Outcome results
None listed