Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site
Overview
- Phase
- Phase 3
- Intervention
- 20 mL topically used during alginate dressing NAROPEINE
- Conditions
- Graft Pain
- Sponsor
- University Hospital, Rouen
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Class II analgesic consumption between the 2 arms
- Status
- Completed
- Last Updated
- 3 months ago
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
Investigators
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)
Arms & Interventions
DRUG : ROPIVACAINE
20 mL topically used during alginate dressing
Intervention: 20 mL topically used during alginate dressing NAROPEINE
PLACEBO : NaCl 0.9 %
20 mL topically used during alginate dressing
Intervention: 20 mL topically used during alginate dressing NaCl
Outcomes
Primary Outcomes
Class II analgesic consumption between the 2 arms
Time Frame: 5 days post-operative
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
Secondary Outcomes
- Class II antalgic consumption between the 2 arms(Day 90)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(day 90)