Analgesic efficacy of levobupivacaine administered by wet wound dressing on skin graft donor site

Phase 1

Conditions: acute postoperative pain
Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Registration Number: EUCTR2015-000232-15-ES

Lead Sponsor: Consorcio Hospital General Universitario de Valencia . Servicio de Anestesia , Reanimacion y tto del Dolor

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients> 18 and <= 75 years. 2. Patients had an split-thickness skin graft donor site area of 50?150 cm2. 3. Skin graft donor site anterior or
posterior thigh. 4. Hospitalization of at least 72 hours. 5. Informed consent signed
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 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Rejection of the patient 2. Surgical procedure superior than 6hrs.3.Other conditions that warrant their inclusion as medically indicated: severe kidney illness (grade 3-4). severe hepatic illness (ChildPugh B and C grades), psychiatric illness), arrythmias, coagulation disorders, preganacy o lactation.
4. Allergy to NSAIDs, local anesthetics and / or opioids. 5. Alcoholism. 6. Abuse drugs. 7. ASA III or higher 8. When the surgery procedure time is 1 hour
more from the moment of obtention of the graft

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluate the analgesic efficacy of L-Bupivacaine 0.75% (max 20 ml) vs.placebo (saline) administered by wet wound dressing for the management split-thickness skin graft donor sites;Secondary Objective: 1 . Assess pain intensity at 24h by VAS. 2. Set the difference in analgesic requirements of intravenous tramadol consumption, as rescue medication, in each of the groups at 24 hours after the end of anesthesia. 3. Assess pain intensity at 72h by VAS. 4. the time until reepithelialization (up to 15 days).;Primary end point(s): Patient-reported postoperative pain, evaluated by a Visual Analog Scale (VAS);Timepoint(s) of evaluation of this end point: At 6 hours from wet wound dressing is placed over donor site.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy: 1.Patient-reported postoperative pain. evaluated by a Visual Analog Scale (VAS). 2. Intravenous Tramadol used (mg).<br> 3. the time until reepithelialization of donor site. <br>Safety: 1. Adverse events and unwanted systemic and locally side effects that the patient relate and observed by investigators. 2. Other explorations carried out occasionally or symptoms that the patient relate.;Timepoint(s) of evaluation of this end point: Efficacy: 1. At 24 and 72 hours from wet wound dressing is placed over donor site, in point number 1. 2. At 24 hours, in point number 2. 3. From 7th to 15th days (every 72 hours), after surgery, in point number 3.<br>Safety: Every study visits.