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

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Epidermolysis Bullosa

Treatments

Drug: Ropivacaine

Biological: Blood test

Study type

Interventional

Funder types

Other

Identifiers

NCT03730584

D20180207

2018-003334-33 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

Under 21 years old

Volunteers

No 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