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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT03730584

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epidermolysis Bullosa	Drug: Ropivacaine Biological: Blood test	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 27, 2017

Actual Primary Completion Date :

Nov 28, 2019

Actual Study Completion Date :

Nov 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient with Hereditary Epidermolysis Bullosa	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

Arm

Intervention/Treatment

Experimental: Patient with Hereditary Epidermolysis Bullosa

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

Outcome Measures

Primary Outcome Measures

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

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
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
Measurement of Local or systemic side effects [Day 5]
Evaluation of tolerance of Ropivacaine
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Necker Enfants Malades	Paris		France	75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Study Director: Christine Bodemer, MD, PhD, Assistance Publique - Hôpitaux de Paris
Principal Investigator: Céline Greco, MD, Assistance Publique - Hôpitaux de Paris