Clinical Trials Register

Summary
EudraCT Number:	2012-002123-15
Sponsor's Protocol Code Number:	RBHP2012JOUVE
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-09-05
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2012-002123-15

A.3

Full title of the trial

Intérêt d’un bloc nerveux bi-tronculaire (fémoral + sciatique) prolongé associé systématiquement à l’anesthésie générale au cours du pontage fémoro-poplité : étude de l'analgésie post-opératoire et de la circulation périphérique d’aval.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

BLOC-FEMPOP

A.4.1

Sponsor's protocol code number

RBHP2012JOUVE

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	CHU de clermont-Ferrand
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	CHU de Clermont-Ferrand
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CHU de clermont-Ferrand
B.5.2	Functional name of contact point	Patrick Lacarin
B.5.3	Address:
B.5.3.1	Street Address	58 rue Montalembert
B.5.3.2	Town/ city	Clermont-Ferrand
B.5.3.3	Post code	63000
B.5.3.4	Country	France
B.5.4	Telephone number	003373751195
B.5.5	Fax number	003373754730
B.5.6	E-mail	placarin@chu-clermontferrand.fr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	CHIROCAÏNE 2,5 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBOT France
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	CHIROCAÏNE 2,5 mg/ml
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	27262-48-2
D.3.9.3	Other descriptive name	LEVOBUPIVACAINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB02904MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2,5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	CHIROCAÏNE 5 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBOT FRANCE
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	CHIROCAÏNE 5 mg/ml
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOBUPIVACAINE
D.3.9.1	CAS number	27262-47-1
D.3.9.4	EV Substance Code	SUB08464MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	CATAPRESSAN 0,15 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	BOEHRINGER INGELHEIM FRANCE
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	CATAPRESSAN 0,15 mg/ml
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CLONIDINE
D.3.9.1	CAS number	4205-90-7
D.3.9.4	EV Substance Code	SUB06730MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/kg microgram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Post-operative pain

E.1.1.1

Medical condition in easily understood language

Post-operative pain

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10036286
E.1.2	Term	Post-operative pain
E.1.2	System Organ Class	10022117 - Injury, poisoning and procedural complications

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

E.2.2

Secondary objectives of the trial

Evaluer, chez les patients opérés d’un pontage fémoro-poplité, le bénéfice d’un double bloc nerveux périphérique (fémoral + sciatique) par lévobupivacaïne et clonidine en dose unique réalisé avant l’induction de l’anesthésie générale, sur :
-la douleur post-opératoire par un score ENS (Echelle Numérique Simple) au repos et à la mobilisation en SSPI puis pendant les 72 premières heures post-opératoires ;
-la circulation périphérique d’aval (mesurée au niveau sural par NIRS) pendant les 12 premières heures post-opératoires ;
-le délai de reprise de la déambulation ;
-les effets indésirables de la morphine en SSPI et dans le service ;
-les effets indésirables imputables au double bloc, y compris ceux imputables à la clonidine (bradycardie, hypotension, somnolence, vertiges) ;
-la durée de séjour hospitalier ;
-la morbi-mortalité post-opératoire.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients devant bénéficier d’un pontage fémoro-poplité programmé dans le cadre d’une artériopathie oblitérante des membres inférieurs (AOMI) de stade II ou III .
-Agés de 18 à 80 ans.
-Ayant donné leur consentement selon les modalités décrites par le titre II du livre du premier Code de Santé Publique.
-Affiliés à un régime de la Sécurité Sociale.

E.4

Principal exclusion criteria

-Patients présentant une AOMI de stade I ou IV.
-Insuffisance respiratoire chronique.
-Insuffisance coronarienne sévère.
-Insuffisance rénale ou hépatique sévère.
-Patients présentant des douleurs chroniques ou un traitement opiacé pré-opératoire au long cours.
-Patients présentant des troubles cognitifs (jugés par l’investigateur) pouvant gêner :
o le consentement éclairé,
o le recueil des critères de jugement,
o l’usage de l’analgésie auto-contrôlée.
-Anomalie sévère de l’hémostase (plaquettes < 80.000 / ml) et/ou de la coagulation (TP < 50%, facteur V < 50%).
-Patients présentant un diabète insulino-dépendant et/ou une neuropathie diabétique.
-Femmes enceintes ou allaitantes, femmes en âge de procréer.
-Refus du protocole.
-Patients mineurs ou majeurs protégés.
-Contre-indications à l’un des produits suivants :
o lévobupivacaïne,
o clonidine,
o morphine,
o paracétamol,
o néfopam.

E.5 End points

E.5.1

Primary end point(s)

Consommation totale de morphine (en milligrammes) administrée soit par titration intraveineuse en salle de surveillance post-interventionnelle (SSPI), soit par dispositif d’administration auto-contrôlée (patient-controlled analgesia, PCA) pendant les 24 premières heures post-opératoires.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 heures après extubation

E.5.2

Secondary end point(s)

-Consommation totale de morphine (en milligrammes) administrée par titration intraveineuse par une infirmière en salle de surveillance post-interventionnelle (SSPI), pour l’obtention d’un score de douleur (ENS ) en sortie de SSPI inférieur ou égal à 3.
-Consommation totale de morphine (en milligrammes) administrée soit par titration intraveineuse en salle de surveillance post-interventionnelle (SSPI), soit par dispositif d’administration autocontrôlée (patient-controlled analgesia, PCA), soit par voie orale, pendant les 72 premières heures post-opératoires.
- Scores de douleur mesurée par échelle numérique simple (ENS) au repos et à la mobilisation aux temps suivants :
o 30, 60, 90, et 120 minutes après l’extubation,
o à la sortie de SSPI,
o puis toutes les 4 heures pendant les 24 heures post-opératoires,
o puis toutes les 8 heures pendant les 48 heures suivantes.
- Consommation de sufentanil (en microgrammes) per-opératoire.
- La rSO2 mesurée par NIRS à l’étage sural en continu pendant 12 heures.
- Délai entre la sortie du bloc et la reprise de la déambulation.
- Taux de reprise chirurgicale dans les 30 jours suivant l’intervention.
- Durée de séjour hospitalier.
- Taux de mortalité au 30ème jour post-opératoire.
- Score de sédation OAA/S mesurée aux temps suivants :
o 30 minutes après l’extubation,
o toutes les heures jusqu’à la sortie de SSPI,
o puis toutes les 8 heures pendant les 24 heures post-opératoires.
- Tolérance hémodynamique, nausées et vomissements.
- Score hémorragique .
- Taux de survenue de complications cardiaques (troubles du rythme, syndrome coronarien aigu, infarctus du myocarde, insuffisance cardiaque, arrêt cardiaque) et d’infection du site opératoire à la sortie du patient.

E.5.2.1

Timepoint(s) of evaluation of this end point

-Consommation morphine : en sortie de SSPI
-Consommation morphine : pendant 72 heures post-opératoires.
-Scores de douleur : à 30', 60', 90', et 120 minutes après l’extubation, à la sortie de SSPI, puis toutes les 4 heures pendant les 24 heures post-opératoires, puis toutes les 8 heures pendant les 48 heures suivantes.
-Consommation sufentanil : per-opératoire.
-La rSO2 : pendant 12 heures.
-Taux de reprise chirurgicale : à 30 jours
-Taux de mortalité au 30ème jour post-opératoire.
-Score de sédation OAA/S : 30 minutes après l’extubation, toutes les heures jusqu’à la sortie de SSPI, puis toutes les 8 heures pendant les 24 heures post-opératoires.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Definition of the end of the trial = last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Prise en charge habituelle de la pathologie étudiée

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-08-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-11

P. End of Trial
P.	End of Trial Status	Completed

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