Clinical Trials Register

Summary
EudraCT Number:	2018-004986-15
Sponsor's Protocol Code Number:	Protocol_AFCN_17022019
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-01-03
Trial results	View 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

Denmark - DHMA

A.2

EudraCT number

2018-004986-15

A.3

Full title of the trial

Ultrasound-guided nerve block of the anterior femoral cutaneous nerves in healthy volunteers

Ultralydsvejledt nerveblokade af de anteriore kutane grene fra n. femoralis hos raske forsøgspersoner

A.3.1

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

A study in healthy volunteers investigating the effect of injecting local anesthetic on the front of the thigh under ultrasound-guidance in order to anesthetize the skin on the front of the thigh and knee

Et studie som undersøger effekten af at indsprøjte lokalbedøvelse på forsiden af låret under ultralydsvejledning for at bedøve de nervegrene, som forsyner huden på forsiden af låret og knæet

A.4.1

Sponsor's protocol code number

Protocol_AFCN_17022019

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	Aarhus University Hospital
B.1.3.4	Country	Denmark
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	Korningfonden
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Knud og Edith Eriksens Mindefond
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Sallingfonden
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	A.P. Møller Fond og Hustru Chastine Mc-Kinney Møllers Fond til Almene Formaal
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Aarhus University
B.5.2	Functional name of contact point	Siska Bjørn
B.5.3	Address:
B.5.3.1	Street Address	Thunøgade 21
B.5.3.2	Town/ city	Aarhus C
B.5.3.3	Post code	8000
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+4560651087
B.5.6	E-mail	siska.bjoern@post.au.dk

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	Ropivacain
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi AB
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Ropivacain
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	Perineural use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	84057-95-4
D.3.9.3	Other descriptive name	ROPIVACAINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04264MIG
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	5.0
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
D.8.4	Route of administration of the placebo	Perineural use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pain around the surgical incision after total knee arthroplasty (TKA).
The area anesthetized by a combination of nerve block techniques anesthetizing the anterior femoral cutaneous nerves are investigated in healthy volunteers to see if the relevant area around the surgical incision site is anesthetized.

Smerter fra den kirurgiske incision efter total knæalloplastik (TKA).
Det område, som anæsteseres ved en kombination af nye nerveblokadeteknikker, som skal anæstesere de anteriore kutane grene fra n. femoralis, undersøges i raske frivillige forsøgspersoner for at se, om det relevante område svarende til den kirurgiske incision anæsteseres.

E.1.1.1

Medical condition in easily understood language

Pain around the surgical incision after total knee joint replacement.

Smerter omkring det snit kirurgen laver i huden efter indsættelse af knæledsprotese.

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10036236
E.1.2	Term	Postoperative pain relief
E.1.2	System Organ Class	100000004865

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
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.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10045434
E.1.2	Term	Ultrasound scan
E.1.2	System Organ Class	10022891 - Investigations

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 primary objective is to investigate the success rate of complete anesthesia of the surgical incision used for TKA after proximal femoral triangle block (FTB) combined with a block of the intermediate femoral cutaneous nerves (IFCNB) compared to proximal FTB alone.

Undersøgelsens primære formål er at undersøge succesraten for komplet anæstesi af den midtlinjeincision, som benyttes ved TKA, efter proksimal trigonum femoralis blokade (FTB) i kombination med blokade af de intermediære kutane grene fra n. femoralis (IFCNB) sammenlignet med proksimal FTB alene.

E.2.2

Secondary objectives of the trial

The secondary objectives of the trial are to investigate the success rate of complete anesthesia of the surgical incision after the different nerve blocks (distal FTB, proximal FTB, IFCNB) alone and in combination. The change in muscle strength is evaluated from before to after placement of the nerve blocks. Moreover the areas anesthetized after proximal FTB and after IFCNB are evaluated and reported as the maximal extension in proximal, distal, medial and lateral direction. Other secondary objectives include the time used for placement of proximal FTB and IFCNB and an evaluation of the discomfort during nerve block placement for each of the different blocks.

Undersøgelsens sekundære formål er at undersøge succesraten af komplet anæstesi sv.t. incisionslinjen for de forskellige nerveblokader alene og i kombination. Derudover vurderes ændringen i muskelstyrke fra før til efter blokadeanlæggelse for de forskellige blokader. Desuden er undersøgelsens formål at vurdere udbredelsen af det anæsteserede hudområde efter hhv. proksimal FTB og IFCNB angivet som maksimal udbredelse i proksimal, distal, lateral og medial retning. Andre sekundære effektmål inkluderer anlæggelsestiden for proksimal FTB og IFCNB samt en vurdering af ubehaget ved anlæggelse af de tre nerveblokader.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age ≥ 18 years
American Society of Anesthesiologists physical status classification score (ASA) I-II
Informed consent

Alder ≥ 18 år
American Society of Anesthesiologists physical status classification score (ASA) I-II
Informeret samtykke

E.4

Principal exclusion criteria

Unable to cooperate
Unable to speak or understand Danish
Known neuropathy in the extremities
Chronic, opioid-requiring pain
Infection in the areas around the injection sites
Obesity (Body Mass Index, BMI > 28 kg/m2)
Body weight < 60 kg
Pregnancy
Allergy towards any medical product used in the trial

Manglende evne til samarbejde
Manglende danskkundskaber
Kendt neuropati i underekstremiteter
Kroniske, opioidkrævende smerter
Infektion i området omkring indstiksstederne for nerveblokaderne
Overvægt (Body Mass Index, BMI) > 28 kg/m2)
Vægt < 60 kg
Graviditet
Overfølsomhed for de anvendte lægemidler

E.5 End points

E.5.1

Primary end point(s)

Success rate of complete anesthesia of the incision line with active proximal FTB combined with active IFCNB compared to active proximal FTB in combination with placebo IFCNB.

Succesrate for dækning af hele incisionlinjen med anæstesi efter aktiv proksimal FTB kombination med aktiv IFCNB sammenlignet med aktiv proksimal FTB i kombination med placebo IFCNB.

E.5.1.1

Timepoint(s) of evaluation of this end point

Cutaneous anesthesia is evaluated using pin-prick testing after:
1) placement of the first four nerve blocks (distal and proximal FTB in each leg).
2) placement of IFCNB in each leg.

Kutan anæstesi evalueres med pin-prick test efter:
1) anlæggelse af de første fire nerveblokader (distal og proksimal FTB i hvert ben).
2) anlæggelse af IFCNB i hvert ben.

E.5.2

Secondary end point(s)

1) Change in muscle strength of the quadriceps muscle from baseline to after block placement on the leg with active distal FTB compared to the leg with active proximal FTB.
2) Change in muscle strength of the quadriceps muscle from before IFCNB to after IFCNB on the leg with active distal FTB.
3) Change in muscle strength of the quadriceps muscle from before IFCNB to after IFCNB on the leg with active proximal FTB.
4) Maximal extension of cutaneous anesthesia after distal FTB measured in the proximal, distal, medial and lateral direction.
5) Maximal extension of cutaneous anesthesia after proximal FTB measured in the proximal, distal, medial and lateral direction.
6) Maximal extension of cutaneous anesthesia after IFCNB measured in the proximal, distal, medial and lateral direction.
7) Time spent on distal FTB placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle.
8) Time spent on proximal FTB placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle.
9) Time spent on IFCNB placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle.
10) Discomfort during placement of distal FTB (Numerical rating scale, NRS 0-10).
11) Discomfort during placement of proximal FTB (NRS 0-10).
12) Discomfort during placement of IFCNB (NRS 0-10).
13) Success rate of complete anesthesia of the incision line with distal FTB alone.
14) Success rate of complete anesthesia of the incision line with proximal FTB alone.
15) Success rate of complete anesthesia of the incision line with IFCNB alone on the leg with active distal FTB.
16) Success rate of complete anesthesia of the incision line with distal FTB compared to distal FTB combined with IFCNB.
17) Presence of a gap (defined as a skin area with no anesthesia) involving the incision line
18) Presence of a gap (defined as a skin area with no anesthesia) involving the anteromedial knee area

1) Ændring i muskelstyrke af m. quadriceps fra baseline til efter blokadeanlæggelse på det ben, hvor der er anlagt aktiv distal FTB sammenlignet med det ben, hvor der er anlagt aktiv proksimal FTB.
2) Ændring i muskelstyrke af m. quadriceps fra før IFCNB anlæggelse til efter IFCNB anlæggelse på det ben, hvor der er anlagt aktiv distal FTB.
3) Ændring i muskelstyrke af m. quadriceps fra før IFCNB anlæggelse til efter IFCNB anlæggelse på det ben, hvor der er anlagt aktiv proksimal FTB.
4) Den maksimale udbredelse af distal FTB målt proksimalt, distalt, medialt og lateralt.
5) Den maksimale udbredelse af proksimal FTB målt proksimalt, distalt, medialt og lateralt.
6) Den maksimale udbredelse af IFCNB målt proksimalt, distalt, medialt og lateralt.
7) Tidsforbrug til distal FTB anlæggelse. Tidsforbruget er defineret ved tiden fra start af ultralydsscanning til udtrækning af blokadenålen.
8) Tidsforbrug til proksimal FTB anlæggelse. Tidsforbruget er defineret ved tiden fra start af ultralydsscanning til udtrækning af blokadenålen.
9) Tidsforbrug til IFCNB anlæggelse. Tidsforbruget er defineret ved tiden fra start af ultralydsscanning til udtrækning af blokadenålen.
10) Ubehaget under anlæggelse af distal FTB (NRS-skala fra 0 til 10).
11) Ubehaget under anlæggelse af proksimal FTB (NRS-skala fra 0 til 10).
12) Ubehaget under anlæggelse af IFCNB (NRS-skala fra 0 til 10).
13) Succesrate for komplet dækning af incisionslinjen med distal FTB alene.
14) Succesrate for komplet dækning af incisionslinjen med proksimal FTB alene.
15) Succesrate for komplet dækning af incisionslinjen med IFCNB alene på det ben, hvor der er anlagt aktiv distal FTB.
16) Succesrate for komplet dækning af incisionslinjen med distal FTB sammnenlignet med distal FTB i kombination med IFCNB.
17) Tilstedeværelse af et gap (ikke-anæsteseret område) sv.t. incisonclinjen.
18) Tilstedeværelse af et gap (ikke-anæsteseret område) sv.t. anteromediale område.

E.5.2.1

Timepoint(s) of evaluation of this end point

Muscle strength test: evaluated at baseline (right after inclusion before any block placement), after the first four nerve blocks (proximal and distal FTB in each leg) and after IFCNB.

Sensation to pin-prick (cutaneous anesthesia): evaluated at baseline (right after inclusion before any block placement), after the first four nerve blocks (proximal and distal FTB in each leg) and after IFCNB.
Discomfort during block placement: Evaluated after placement of IFCNB.

Presence of a gap: Evaluated after IFCNB placement.

Muskelstyrke: evalueres ved baseline (lige efter inklusion, før anlæggelse af blokader), efter de første fire nerveblokader og efter IFCNB.

Sensorisk test med pin-prick (kutan anæstesi): evalueres ved baseline (lige efter inklusion, før anlæggelse af blokader), efter de første fire nerveblokader og efter IFCNB.

Ubehag under blokadeanlæggelse: evalueres efter anlægelse af IFCNB.

Tilstedeværelse af et gap: evalueres efter anlæggelse af IFCNB.

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

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

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.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

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-01-03.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

Ingen

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

2019-01-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-02-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-04-07

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