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

Epidermolysis Bullosa Clinical Trial

— EBROPI  

Official title:

Evaluation of the Efficacy of a Topical Analgesic Treatment With ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730584
• Other study ID #: D20180207
• Secondary ID: 2018-003334-33
• Status: Completed
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: November 28, 2019

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 28, 2019
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidermolysis Bullosa

Intervention

Drug:
• Ropivacaine
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.

Biological:
• Blood test
Blood test during the first bath with Ropivacaine for Titration of Ropivacaine

Locations

Country	Name	City	State
France	Hôpital Necker Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Day 5
Secondary	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	Day 21
Secondary	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	Day 21
Secondary	Measurement of Local or systemic side effects	Evaluation of tolerance of Ropivacaine	Day 5
Secondary	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	Day 21
Secondary	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	Day 21
Secondary	Systemic passage of Ropivacaine	Evaluation of the systemic passage of Ropivacaine	Blood test during the first bath with Ropivacaine up to Day 4