Clinical Trials Register

Summary
EudraCT Number:	2016-001413-24
Sponsor's Protocol Code Number:	35RC15_8933_TAP-ALIF
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:	2020-10-30
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

2016-001413-24

A.3

Full title of the trial

Intérêt du TAP (Transverse Abdominis Plane) bloc bilatéral échoguidé pour l’analgésie post opératoire des chirurgies rachidiennes par voie antérieure.

A.3.1

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

Intérêt de la réalisation ou non d'une anesthésie locorégionale (TAP bloc bilatéral échoguidé) sur les douleurs post opératoire des chirurgies du rachis.

A.3.2

Name or abbreviated title of the trial where available

TAP ALIF

A.4.1

Sponsor's protocol code number

35RC15_8933_TAP-ALIF

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 Rennes
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	Société Française d'Anesthésie et de Réanimation (SFAR)
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 Rennes
B.5.2	Functional name of contact point	Visseiche
B.5.3	Address:
B.5.3.1	Street Address	2 rue Henri Le Guilloux
B.5.3.2	Town/ city	Rennes
B.5.3.3	Post code	35033
B.5.3.4	Country	France
B.5.4	Telephone number	33299 28 97 47
B.5.5	Fax number	33299 28 37 22
B.5.6	E-mail	valerie.visseiche@chu-rennes.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	ROPIVACAÏNE KABI
D.2.1.1.2	Name of the Marketing Authorisation holder	FRESENIUS KABI FRANCE SA
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	ROPIVACAINE KABI
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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	Solution for injection/infusion
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chirurgie du rachis

E.1.1.1

Medical condition in easily understood language

Chirurgie du rachis

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10002325
E.1.2	Term	Anesthesia local
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Comparer la consommation morphinique postopératoire en chirurgie rachidienne par voie antérieure après un TAP bloc bilatéral avec ropivacaine versus placebo, réalisé sous échoguidage.

E.2.2

Secondary objectives of the trial

- Comparer les scores numériques de douleur postopératoire
- Comparer l’incidence des effets secondaires liés aux morphiniques, en particulier les nausées et vomissements postopératoires (NVPO) et retards de transit au cours des 48 premières heures
- Comparer la durée d’hospitalisation

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Sujet âgé de plus de 18 ans;
- Chirurgie rachidienne par voie antérieure avec incision de Pfannenstiel ;
- Signature du consentement éclairé.

E.4

Principal exclusion criteria

- Hypersensibilité à la ROPIVACAINE ;
- Poids < 50kg ;
- Contre-indication à la réalisation du TAP bloc : sepsis au point de ponction, trouble de coagulation ;
- Contre-indication au PARACETAMOL : hypersensibilité, insuffisance hépatique sévère ;
- Contre-indication à l’utilisation du KETOPROFENE : âge ≥ 75 ans, insuffisance rénale, antécédent ulcère gastroduodénal, hypersensibilité ;
- Contre-indication à l’utilisation du NEFOPAM : insuffisance cardiaque sévère, glaucome par fermeture de l’angle, hypertrophie bénigne de prostate, hypersensibilité ;
- Hypersensibilité connue à la substance active ou à l’un des excipients (Propofol, paracetamol, skenan/actiskenan, ultiva, cisatracurium) ;
- Hypersensibilité aux dérivés du fentanyl, à l’atracurium ou à l’acide benzène sulfonique (acide bésilique), au propacétamol (prodrogue du paracetamol) ;
- Convulsions ou antécédents de troubles convulsifs ;
- Insuffisance respiratoire décompensée ;
- Trouble de l’hémostase ou traitement anticoagulant en cours, en raison de l’utilisation de la voie intra-musculaire ;
- Prise de MORPHINIQUE (SKENAN, ACTISKENAN, OXYCONTIN, OXYNORM, …) dans les 24 heures avant la chirurgie ;
- Femmes enceintes et allaitantes ;
- Les incapables protégés (sauvegarde de justice, curatelle et tutelle) et les personnes privées de libertés.

E.5 End points

E.5.1

Primary end point(s)

Consommation de morphiniques des 24 premières heures postopératoires (titration Morphine en SSPI et PCA Morphine).

E.5.1.1

Timepoint(s) of evaluation of this end point

H24

E.5.2

Secondary end point(s)

1. Consommation de morphiniques des 48 premières heures postopératoire
2. Niveau de douleur mesuré par une échelle numérique simple (ENS) à H1 H24 et H48 après la chirurgie et au 1er lever
3. Délai avant la première administration de morphinique
4. Incidence des Nausées Vomissements Post Opératoires (NVPO) en SSPI pendant les 48 premières heures
5. Délai avant le premier lever
6. Délai avant reprise du transit
7. Durée d’hospitalisation
8. Incidence de complications du TAP bloc
9. Score de satisfaction des patients par un questionnaire standardisé

E.5.2.1

Timepoint(s) of evaluation of this end point

H1, H24, H48, premier lever

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

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

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)

Yes

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

Dernière visite du dernier patient

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

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)

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)

None

Non

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-06-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-05-25

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