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

Overview[ - collapse ][ - ]

Purpose 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
ConditionGraft Pain
InterventionDrug: 20 mL topically used during alginate dressing NAROPEINE
Drug: 20 mL topically used during alginate dressing NaCl
PhasePhase 3
SponsorUniversity Hospital, Rouen
Responsible PartyUniversity Hospital, Rouen
ClinicalTrials.gov IdentifierNCT01999153
First ReceivedJuly 29, 2013
Last UpdatedMarch 12, 2014
Last verifiedMarch 2014

Tracking Information[ + expand ][ + ]

First Received DateJuly 29, 2013
Last Updated DateMarch 12, 2014
Start DateDecember 2013
Estimated Primary Completion DateMarch 2016
Current Primary Outcome MeasuresClass II analgesic consumption between the 2 arms [Time Frame: 5 days post-operative] [Designated as safety issue: No]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
Current Secondary Outcome Measures
  • Class II antalgic consumption between the 2 arms [Time Frame: Day 90] [Designated as safety issue: No]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 [Time Frame: day 90] [Designated as safety issue: Yes]potential side effects of ropivacaine on the healing of skin graft donor site

Descriptive Information[ + expand ][ + ]

Brief TitleEvaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site
Official TitleEvaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin 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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionGraft Pain
InterventionDrug: 20 mL topically used during alginate dressing NAROPEINE
20 mL topically used during alginate dressing
Other Names:
Brand name of drug use NAROPEINEDrug: 20 mL topically used during alginate dressing NaCl
20 mL topically used during alginate dressing
Other Names:
NaCl 0.9 %
Study Arm (s)
  • Experimental: DRUG : ROPIVACAINE
    20 mL topically used during alginate dressing
  • Placebo Comparator: PLACEBO : NaCl 0.9 %
    20 mL topically used during alginate dressing

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment88
Estimated Completion DateMarch 2016
Estimated Primary Completion DateFebruary 2016
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)
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Dorothée COQUEREL, MD
+33232888760
dorothee.coquerel-beghin@chu-rouen.fr
Location CountriesFrance

Administrative Information[ + expand ][ + ]

NCT Number NCT01999153
Other Study ID Numbers2012/119/HP
Has Data Monitoring CommitteeNo
Information Provided ByUniversity Hospital, Rouen
Study SponsorUniversity Hospital, Rouen
CollaboratorsNot Provided
Investigators Principal Investigator: Dorothée COQUEREL-BEGHIN, MD University Hospital, Rouen
Verification DateMarch 2014

Locations[ + expand ][ + ]

UHRouen
Rouen, France, 76031
Contact: dorothée COQUEREL-BEGHIN, Md | +33232888760 | dorothee.coquerel-beghin@chu-rouen.fr
Principal Investigator: Dorothée COQUEREL-BEGHIN, MD
Recruiting