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

NCT03730584 | Completed

• 2 other identifiers: D201802072018-003334-33
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidermolysis Bullosa

Keywords

Hereditary Epidermolysis Bullosa; pain; bath; dressing change; Ropivacaine; topical application

Outcome Measures

Primary Outcomes (1)

• 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

  Day 5

Secondary Outcomes (7)

• Efficacy on pain of Ropivacaine at the time of dressing change

  Day 5

• Efficacy on pain of Ropivacaine at home at the time of dressing change

  Day 21

• Efficacy on pain of Ropivacaine at home at bath entrance

  Day 21

• Measurement of Local or systemic side effects

  Day 5

• Efficacy of Ropivacaine on the reduction of opioids use

  Day 21

Study Arms (1)

Patient with Hereditary Epidermolysis Bullosa

EXPERIMENTAL

Drug: Ropivacaine; Biological: Blood test

Interventions

Ropivacaine DRUG

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.

Patient with Hereditary Epidermolysis Bullosa

Blood test BIOLOGICAL

Blood test during the first bath with Ropivacaine for Titration of Ropivacaine

Patient with Hereditary Epidermolysis Bullosa

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Minor patient or adult ≤ 21 years of age with hereditary epidermolysis bullosa,
• Usually requiring premedication with weak or strong opioid
• Parental consent if minor or patient consent
• Affiliated with Social Security

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Related Publications (2)

• 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.

  PMID: 32939751 RESULT

• Chevret S, Verlhac S, Ducros-Miralles E, Dalle JH, de Latour RP, de Montalembert M, Benkerrou M, Pondarre C, Thuret I, Guitton C, Lesprit E, Etienne-Julan M, Elana G, Vannier JP, Lutz P, Neven B, Galambrun C, Paillard C, Runel C, Jubert C, Arnaud C, Kamdem A, Brousse V, Missud F, Petras M, Doumdo-Divialle L, Berger C, Freard F, Taieb O, Drain E, Elmaleh M, Vasile M, Khelif Y, Bernaudin M, Chadebech P, Pirenne F, Socie G, Bernaudin F. Design of the DREPAGREFFE trial: A prospective controlled multicenter study evaluating the benefit of genoidentical hematopoietic stem cell transplantation over chronic transfusion in sickle cell anemia children detected to be at risk of stroke by transcranial Doppler (NCT 01340404). Contemp Clin Trials. 2017 Nov;62:91-104. doi: 10.1016/j.cct.2017.08.008. Epub 2017 Aug 15.

  PMID: 28821470 RESULT

MeSH Terms

Conditions

Epidermolysis Bullosa; Pain

Interventions

Ropivacaine; Hematologic Tests

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Christine Bodemer, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Céline Greco, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 5, 2018
• Study Start: February 27, 2017
• Primary Completion: November 28, 2019
• Study Completion: November 28, 2019
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)