Graft Pain
Conditions
Keywords
skin graft, donor site
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
Interventions
DRUG20 mL topically used during alginate dressing NaCl
20 mL topically used during alginate dressing
DRUG20 mL topically used during alginate dressing NAROPEINE
20 mL topically used during alginate dressing
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Class II analgesic consumption between the 2 arms | 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
| Measure | Time frame | Description |
|---|---|---|
| Class II antalgic consumption between the 2 arms | Day 90 | evaluate the effect of ropivacaine on postoperative pain at the skin graft donor site |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | day 90 | potential side effects of ropivacaine on the healing of skin graft donor site |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORDorothée COQUEREL-BEGHIN, MD
University Hospital, Rouen
Outcome results
None listed