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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01999153
Recruitment Status : Unknown
Verified June 2017 by University Hospital, Rouen.
Recruitment status was:  Recruiting
First Posted : December 3, 2013
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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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


Condition or disease Intervention/treatment Phase
Graft Pain Drug: 20 mL topically used during alginate dressing NAROPEINE Drug: 20 mL topically used during alginate dressing NaCl Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site
Study Start Date : December 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arms and Interventions
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Arm Intervention/treatment
Experimental: DRUG : ROPIVACAINE
20 mL topically used during alginate dressing
 Drug: 20 mL topically used during alginate dressing NAROPEINE
20 mL topically used during alginate dressing
Other Name: Brand name of drug use NAROPEINE
Placebo Comparator: PLACEBO : NaCl 0.9 %
20 mL topically used during alginate dressing
 Drug: 20 mL topically used during alginate dressing NaCl
20 mL topically used during alginate dressing
Other Name: NaCl 0.9 %


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Class II antalgic consumption between the 2 arms [ Time Frame: Day 90 ]
    evaluate the effect of ropivacaine on postoperative pain at the skin graft donor site

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: day 90 ]
    potential side effects of ropivacaine on the healing of skin graft donor site


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999153


Contacts
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Contact: Dorothée COQUEREL, MD +33232888760 dorothee.coquerel-beghin@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
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France
UHRouen Recruiting
Rouen, France, 76031
Contact: dorothée COQUEREL-BEGHIN, Md    +33232888760    dorothee.coquerel-beghin@chu-rouen.fr   
Principal Investigator: Dorothée COQUEREL-BEGHIN, MD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Dorothée COQUEREL-BEGHIN, MD University Hospital, Rouen
More Information
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01999153    
Other Study ID Numbers: 2012/119/HP
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Keywords provided by University Hospital, Rouen:
skin graft
donor site
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents