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Evaluation of the Efficacy of ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa (EBROPI)

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ClinicalTrials.gov Identifier: NCT03730584
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
The purpose of this study is to determine whether topical application of Ropivacaine is effective for treating refractory pain during dressing changes and so improve quality of life of patients (newborn, child, adolescent or adults under 21) suffering from hereditary epidermal epidermolysis bullosa.

Condition or disease Intervention/treatment Phase
Epidermolysis Bullosa Drug: Ropivacaine Biological: Blood test Not Applicable

Detailed Description:

This clinical trial aims to determine the efficacy on pain of local application of ROPIVACAINE 0.2% on cutaneous lesions related to Epidermolysis Bullosa during dressing change, associated with the standard premedication.

Patients will be hospitalized and will have several baths. The first bath will be done according to usual protocol (usual premedication 1h before the bath). Pain measurements (Visual analog scale or FLACC) will be done at the entry into the water, in the middle of bath and at the time of the dressing change.

The following baths will be done using local application of Ropivacaine 15 minutes before entering into the water on lesions identified by the patients as the most painful lesions due to Epidermolysis Bullosa.

A blood test will be done during the first use of Ropivacaine to determine plasmatic level of Ropivacaine.

After 3 baths in the dermatology unit, patients will continue such bath at home, every 48h during 15 days.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of a Topical Analgesic Treatment With ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: Ropivacaine
    Ampoules of ROPIVACAINE 2mg / ml will be used by local cutaneous application in soft application with device of "hand shower" on the painful wounds without exceeding the dose of 1mg / kg per bath.
  • Biological: Blood test
    Blood test during the first bath with Ropivacaine for Titration of Ropivacaine

Outcome Measures
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Primary Outcome Measures :
  1. Efficacy on pain of Ropivacaine at the bath entrance [ Time Frame: Day 5 ]
    Evaluation performed by child with a Visual Analog Scale (VAS) or by parents with the Face Legs Activity Cry Consolability questionary (FLACC) - defined by a 2 points loss between day 1 and day 5


Secondary Outcome Measures :
  1. Efficacy on pain of Ropivacaine at the time of dressing change [ Time Frame: Day 5 ]
    Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing

  2. Efficacy on pain of Ropivacaine at home at the time of dressing change [ Time Frame: Day 21 ]
    Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing

  3. Efficacy on pain of Ropivacaine at home at bath entrance [ Time Frame: Day 21 ]
    Evaluation performed by child with a VAS or by parents with FLACC at the time of bath entrance

  4. Measurement of Local or systemic side effects [ Time Frame: Day 5 ]
    Evaluation of tolerance of Ropivacaine

  5. Efficacy of Ropivacaine on the reduction of opioids use [ Time Frame: Day 21 ]
    Efficacy of ROPIVACAINE on the reduction of weak or strong opioids consumption for premedication for the bath and dressing change

  6. Efficacy of Ropivacaine on the reduction of benzodiazepines or hypnotics use [ Time Frame: Day 21 ]
    Efficacy of ROPIVACAINE on the reduction of of benzodiazepines or hypnotics consumption for premedication for the bath and dressing change


Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minor patient or adult ≤ 21 years of age with hereditary epidermolysis bullosa,
  • Presenting pain at the entrance of the bath with an average of EVA or FLACC greater than 4/10 the week before the inclusion
  • Usually requiring premedication with weak or strong opioid
  • Parental consent if minor or patient consent
  • Affiliated with Social Security

Exclusion Criteria:

  • Patient with a known allergy to ROPIVACAINE or other local anesthetics with amide binding or one of the excipients mentioned in the SPC
  • Severe renal insufficiency defined by DFG below 29ml / min
  • Moderate to severe hepatic insufficiency defined by a Child-Pugh B or C score and AST or ALAT greater than 3 times normal
  • Moderate to severe cardiac failure defined by FEGV less than 45% and/or NYHA class II to IV
  • Hypovolemia
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): NCT03730584


Contacts
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Contact: Céline Greco, MD +33 1 42 19 27 28 celine.greco@aphp.fr
Contact: Nelly Briand, PhD +33 1 44 38 18 62 nelly.briand@aphp.fr

Locations
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France
Hôpital Necker Enfants Malades Recruiting
Paris, France, 75015
Contact: Céline Gréco, MD    +33 1 42 19 27 28    celine.greco@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Christine Bodemer, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03730584     History of Changes
Other Study ID Numbers: D20180207
2018-003334-33 ( EudraCT Number )
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hereditary Epidermolysis Bullosa
pain
bath
 dressing change
Ropivacaine
topical application
Additional relevant MeSH terms:
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Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
 Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents