Evaluation of the Efficacy of ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa (EBROPI)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03730584 |
Recruitment Status :
Completed
First Posted : November 5, 2018
Last Update Posted : April 5, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epidermolysis Bullosa | Drug: Ropivacaine Biological: Blood test | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
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 : | February 27, 2017 |
Actual Primary Completion Date : | November 28, 2019 |
Actual Study Completion Date : | November 28, 2019 |

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 |
- Efficacy on pain of Ropivacaine at the bath entrance [ Time Frame: 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
- Efficacy on pain of Ropivacaine at the time of dressing change [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 5 ]Evaluation of tolerance of Ropivacaine
- Efficacy of Ropivacaine on the reduction of opioids use [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Blood test during the first bath with Ropivacaine up to Day 4 ]Evaluation of the systemic passage of Ropivacaine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730584
France | |
Hôpital Necker Enfants Malades | |
Paris, France, 75015 |
Study Director: | Christine Bodemer, MD, PhD | Assistance Publique - Hôpitaux de Paris | |
Principal Investigator: | Céline Greco, MD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT03730584 |
Other Study ID Numbers: |
D20180207 2018-003334-33 ( EudraCT Number ) |
First Posted: | November 5, 2018 Key Record Dates |
Last Update Posted: | April 5, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hereditary Epidermolysis Bullosa pain bath |
dressing change Ropivacaine topical application |
Epidermolysis Bullosa Skin Abnormalities Congenital Abnormalities Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases Skin Diseases, Vesiculobullous |
Ropivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |