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

Not Applicable

Completed

• Conditions: Epidermolysis Bullosa
• Interventions: Drug: Ropivacaine; Biological: Blood test

• Registration Number: NCT03730584
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2017-02-27
• Study First Submitted: 2018-11-02
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-05
• Primary Completion: 2019-11-28
• Study Completion: 2019-11-28
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with Hereditary Epidermolysis Bullosa	Ropivacaine	-
Patient with Hereditary Epidermolysis Bullosa	Blood test	-

Primary Outcome Measures

Name	Time	Method
Efficacy on pain of Ropivacaine at the bath entrance	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

Name	Time	Method
Measurement of Local or systemic side effects	Day 5	Evaluation of tolerance of Ropivacaine
Efficacy on pain of Ropivacaine at home at bath entrance	Day 21	Evaluation performed by child with a VAS or by parents with FLACC at the time of bath entrance
Efficacy of Ropivacaine on the reduction of opioids use	Day 21	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	Day 21	Efficacy of ROPIVACAINE on the reduction of of benzodiazepines or hypnotics consumption for premedication for the bath and dressing change
Systemic passage of Ropivacaine	Blood test during the first bath with Ropivacaine up to Day 4	Evaluation of the systemic passage of Ropivacaine
Efficacy on pain of Ropivacaine at the time of dressing change	Day 5	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	Day 21	Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing

Trial Locations

Locations (1)

Hôpital Necker Enfants Malades; 🇫🇷 Paris, France