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

Primary Purpose

Epidermolysis Bullosa

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ropivacaine
Blood test
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidermolysis Bullosa focused on measuring Hereditary Epidermolysis Bullosa, pain, bath, dressing change, Ropivacaine, topical application

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Necker Enfants Malades

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with Hereditary Epidermolysis Bullosa

Arm Description

Outcomes

Primary Outcome Measures

Efficacy on pain of Ropivacaine at the bath entrance
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

Efficacy on pain of Ropivacaine at the time of dressing change
Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing - defined by a 2 points loss between day 1 and day 5
Efficacy on pain of Ropivacaine at home at the time of dressing change
Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing
Efficacy on pain of Ropivacaine at home at bath entrance
Evaluation performed by child with a VAS or by parents with FLACC at the time of bath entrance
Measurement of Local or systemic side effects
Evaluation of tolerance of Ropivacaine
Efficacy of Ropivacaine on the reduction of opioids use
Efficacy of ROPIVACAINE on the reduction of weak or strong opioids consumption for premedication for the bath and dressing change
Efficacy of Ropivacaine on the reduction of benzodiazepines or hypnotics use
Efficacy of ROPIVACAINE on the reduction of of benzodiazepines or hypnotics consumption for premedication for the bath and dressing change
Systemic passage of Ropivacaine
Evaluation of the systemic passage of Ropivacaine

Full Information

First Posted
November 2, 2018
Last Updated
April 2, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03730584
Brief Title
Evaluation of the Efficacy of ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa
Acronym
EBROPI
Official Title
Evaluation of the Efficacy of a Topical Analgesic Treatment With ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
November 28, 2019 (Actual)
Study Completion Date
November 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermolysis Bullosa
Keywords
Hereditary Epidermolysis Bullosa, pain, bath, dressing change, Ropivacaine, topical application

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with Hereditary Epidermolysis Bullosa
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Blood test
Intervention Description
Blood test during the first bath with Ropivacaine for Titration of Ropivacaine
Primary Outcome Measure Information:
Title
Efficacy on pain of Ropivacaine at the bath entrance
Description
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
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Efficacy on pain of Ropivacaine at the time of dressing change
Description
Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing - defined by a 2 points loss between day 1 and day 5
Time Frame
Day 5
Title
Efficacy on pain of Ropivacaine at home at the time of dressing change
Description
Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing
Time Frame
Day 21
Title
Efficacy on pain of Ropivacaine at home at bath entrance
Description
Evaluation performed by child with a VAS or by parents with FLACC at the time of bath entrance
Time Frame
Day 21
Title
Measurement of Local or systemic side effects
Description
Evaluation of tolerance of Ropivacaine
Time Frame
Day 5
Title
Efficacy of Ropivacaine on the reduction of opioids use
Description
Efficacy of ROPIVACAINE on the reduction of weak or strong opioids consumption for premedication for the bath and dressing change
Time Frame
Day 21
Title
Efficacy of Ropivacaine on the reduction of benzodiazepines or hypnotics use
Description
Efficacy of ROPIVACAINE on the reduction of of benzodiazepines or hypnotics consumption for premedication for the bath and dressing change
Time Frame
Day 21
Title
Systemic passage of Ropivacaine
Description
Evaluation of the systemic passage of Ropivacaine
Time Frame
Blood test during the first bath with Ropivacaine up to Day 4

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Bodemer, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Céline Greco, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Necker Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32939751
Citation
Moreno Artero E, Schinkel N, Chaumon S, Corset I, Rabeony T, Elie C, Bellon N, Bodemer C, Greco C. Efficacy of topical ropivacaine in children and young adults with hereditary epidermolysis bullosa. Br J Dermatol. 2021 Mar;184(3):550-552. doi: 10.1111/bjd.19551. Epub 2020 Nov 2. No abstract available.
Results Reference
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Evaluation of the Efficacy of ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa

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