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 |
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Condition | Graft Pain |
Intervention | Drug: 20 mL topically used during alginate dressing NAROPEINE Drug: 20 mL topically used during alginate dressing NaCl |
Phase | Phase 3 |
Sponsor | University Hospital, Rouen |
Responsible Party | University Hospital, Rouen |
ClinicalTrials.gov Identifier | NCT01999153 |
First Received | July 29, 2013 |
Last Updated | March 12, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | July 29, 2013 |
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Last Updated Date | March 12, 2014 |
Start Date | December 2013 |
Estimated Primary Completion Date | March 2016 |
Current Primary Outcome Measures | Class 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 |
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Descriptive Information[ + expand ][ + ]
Brief Title | Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site |
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Official Title | Evaluation 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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Graft Pain |
Intervention | Drug: 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 88 |
Estimated Completion Date | March 2016 |
Estimated Primary Completion Date | February 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) |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Dorothée COQUEREL, MD +33232888760 dorothee.coquerel-beghin@chu-rouen.fr |
Location Countries | France |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01999153 |
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Other Study ID Numbers | 2012/119/HP |
Has Data Monitoring Committee | No |
Information Provided By | University Hospital, Rouen |
Study Sponsor | University Hospital, Rouen |
Collaborators | Not Provided |
Investigators | Principal Investigator: Dorothée COQUEREL-BEGHIN, MD University Hospital, Rouen |
Verification Date | March 2014 |
Locations[ + expand ][ + ]
UHRouen | Rouen, France, 76031 Contact: dorothée COQUEREL-BEGHIN, Md | +33232888760 | dorothee.coquerel-beghin@chu-rouen.frPrincipal Investigator: Dorothée COQUEREL-BEGHIN, MD Recruiting |
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