Clinical trial NCT03730584: Evaluation of the Efficacy of ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa
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
Overall status: COMPLETED
Phase: NA
Conditions: Epidermolysis Bullosa
Keywords: Hereditary Epidermolysis Bullosa
pain
bath
dressing change
Ropivacaine
topical application
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 10
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy on pain of Ropivacaine at the bath entrance
timeFrame: Day 5
Secondary outcomes:
measure: Efficacy on pain of Ropivacaine at the time of dressing change
timeFrame: Day 5
measure: Efficacy on pain of Ropivacaine at home at the time of dressing change
timeFrame: Day 21
measure: Efficacy on pain of Ropivacaine at home at bath entrance
timeFrame: Day 21
measure: Measurement of Local or systemic side effects
timeFrame: Day 5
measure: Efficacy of Ropivacaine on the reduction of opioids use
timeFrame: Day 21
measure: Efficacy of Ropivacaine on the reduction of benzodiazepines or hypnotics use
timeFrame: Day 21
measure: Systemic passage of Ropivacaine
timeFrame: Blood test during the first bath with Ropivacaine up to Day 4
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Christine Bodemer, MD, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Céline Greco, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.