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

Phase 3CompletedNCT01999153

University Hospital, Rouen58 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Graft Pain

Interventions

20 mL topically used during alginate dressing NAROPEINE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: 5 days post-operative

Secondary Outcomes

Class II antalgic consumption between the 2 arms

evaluate the effect of ropivacaine on postoperative pain at the skin graft donor site

Time frame: 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

Time frame: day 90