Clinical Trials Register

Summary
EudraCT Number:	2015-004607-24
Sponsor's Protocol Code Number:	FICBMRISTUDY2016
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-07-18
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2015-004607-24

A.3

Full title of the trial

Comparison of the spread of local anesthetics in the fascia iliaca compartment between the classical “transverse” technique and the longitudinal supra-inguinal technique.

A.3.1

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

comparison of the spread of a local anesthetic product if we inject it using two different approaches in the inguinal region using magnetic resonance imaging.

A.3.2

Name or abbreviated title of the trial where available

FICBMRISTUDy

A.4.1

Sponsor's protocol code number

FICBMRISTUDY2016

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	AZ Groeninge
B.1.3.4	Country	Belgium
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	AZ Groeninge
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AZ Groeninge
B.5.2	Functional name of contact point	Matthias Desmet
B.5.3	Address:
B.5.3.1	Street Address	President Kennedylaan 4
B.5.3.2	Town/ city	Kortrijk
B.5.3.3	Post code	8500
B.5.3.4	Country	Belgium
B.5.4	Telephone number	3256633077
B.5.6	E-mail	matthias.desmet@azgroeninge.be

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	xylocaine (lidocaine)
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	xylocaine
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Perineural use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	xylocaine
D.3.9.3	Other descriptive name	LIDOCAINE HYDROCHLORIDE 1%
D.3.9.4	EV Substance Code	SUB171122
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

E.1.1.1

Medical condition in easily understood language

In volunteers different approaches of a loco-regional anesthesia techniques will be compared by means of spread of this local anesthetic on MRI and by means of differences in muscular function tests.

E.1.1.2

Therapeutic area

Health Care [N] - Health Care Quality, Access, and Evaluation [N05]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The aim of the study is to compare the spread of local anaesthetics between the classical FICB (cFICB) and the supra-inguinal FICB (sFICB). The spread of local anesthetic in the fascia iliaca compartment will be evaluated with MRI. Motor and sensory block will be measured in the FN, ON and LFCN. spread of local anesthetics will be measured. Our hypothesis is that the longitudinal supra-inguinal approach results in a more consistent block of the three target nerves (FN, ON, LFCN) and will have superior block characteristics. The spread of the MRI local anesthetic solution will be compared between the two techniques. The spread of injectate will be described according to the different anatomical compartments (cranial, caudal, lateral, medial spread). The involvement of the FN, ON, and LFCN will be evaluated by an independent radiologist unaware of study allocation.

E.2.2

Secondary objectives of the trial

Sensory block will be evaluated as described before and after the block performance by an independent examinator unaware of study allocation. The areas of sensory block will be marked on the patient and transferred to paper. A digital photograph will then be taken. This image will be analyzed using Image J software to calculate the area of anaesthesia.
Post intervention strength tests.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

After approval of the ethics committee and written informed consent ten healthy volunteers will be randomly recruited among residents, trainees and medical students.

E.4

Principal exclusion criteria

Exclusion criteria are: age <18 years, BMI >35, bodyweight<70kg, intolerance to local anesthetics used in the study, a history of hepatic or renal insufficiency, coagulopathy, clinical evidence of peripheral neuropathies, cardiac or pulmonary disease, abnormalities of sensory or motor function of the FN, ON or LFCN.

E.5 End points

E.5.1

Primary end point(s)

The aim of the study is to compare the spread of local anaesthetics between the classical FICB (cFICB) and the supra-inguinal FICB (sFICB). The spread of local anesthetic in the fascia iliaca compartment will be evaluated with MRI. Our hypothesis is that the longitudinal supra-inguinal approach results in a more proximal spread ijn comparison with the classical approach.

E.5.1.1

Timepoint(s) of evaluation of this end point

Study will be performed in October 2016. Clinical data will be gathered at that point and will be analysed the weeks following the clinical days.

E.5.2

Secondary end point(s)

Motor and sensory block will be measured in the FN, ON and LFCN. Our hypothesis is that the longitudinal supra-inguinal approach results in a more consistent block of the three target nerves (FN, ON, LFCN) and will have superior block characteristics.

E.5.2.1

Timepoint(s) of evaluation of this end point

Study will be performed in October 2016. Clinical data will be gathered at that point and will be analysed the weeks following the clinical days.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

comparison of two different approaches of a same regional anesthesia technique

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

LVLS

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.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

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)

end of trial is end of treatment

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

2016-08-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-03-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-12-31

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