Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to Evaluate of the analgesic effect of ropivacaine in topical use at the thin skin graft donor site. For Patient needing a thin skin graft < 320 cm2, randomization will be done in 2 groups, one receiving the standard treatment (20 mL of physiologic serum) during the surgical intervention in topical use to recover an alginate dressing (Algosteril)and the other receive 20 mL of Naropein during the surgical intervention on alginate dressing. The hypothesis of the study is the administration of ropivacaine will decrease the post-operative pain compared to physiologic serum

Official Title
-----------------
Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site

Conditions
-----------------
Graft Pain

Intervention / Treatment
-----------------
* Drug: 20 mL topically used during alginate dressing NAROPEINE
* Drug: 20 mL topically used during alginate dressing NaCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years old Patient needing a thin skin graft < 320 cm2 and which is possible on the thigh Patient who read the information letter and signed the informed consent Patient affiliated at a social security system Effective contraceptive method for more than 3 months for women of childbearing age Exclusion Criteria: Contraindication to one of the medicine used (allergy, intolerance, potential drug interaction) Treatment by classII or III of analgesics or analgesic dose of aspirin(>500mg per day) at the inclusion or randomization time Preoperative EVA>0 at the skin graft donor site on the thigh Sensory disturbances of the lower limbs Cognitive disturbances not allowing investigations Pregnant or lactating women People deprived of discernment People deprived of their liberty by judicial or administrative authority Protected adult (guardianship or trusteeship)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DRUG : ROPIVACAINE<br>20 mL topically used during alginate dressing | Drug: 20 mL topically used during alginate dressing NAROPEINE<br>* 20 mL topically used during alginate dressing<br>* Other names: Brand name of drug use NAROPEINE;|
| Placebo Comparator: PLACEBO : NaCl 0.9 %<br>20 mL topically used during alginate dressing | Drug: 20 mL topically used during alginate dressing NaCl<br>* 20 mL topically used during alginate dressing<br>* Other names: NaCl 0.9 %;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Class II analgesic consumption between the 2 arms | Evaluate the effect of ropivacaine in topical use on an alginate dressing by evaluating the use of class II analgesic medicines in patient who had a thin skin graft | 5 days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Class II antalgic consumption between the 2 arms | evaluate the effect of ropivacaine on postoperative pain at the skin graft donor site | Day 90 | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | potential side effects of ropivacaine on the healing of skin graft donor site | day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin graft, donor site