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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRUG : ROPIVACAINE | Experimental | 20 mL topically used during alginate dressing |
|
| PLACEBO : NaCl 0.9 % | Placebo Comparator | 20 mL topically used during alginate dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 mL topically used during alginate dressing NAROPEINE | Drug | 20 mL topically used during alginate dressing |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothée COQUEREL-BEGHIN, MD | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHRouen | Rouen | 76031 | France |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 20 mL topically used during alginate dressing NaCl | Drug | 20 mL topically used during alginate dressing |
|
|
potential side effects of ropivacaine on the healing of skin graft donor site
| day 90 |
| D017670 |
| Sodium Compounds |