Clinical Trials Register

Summary
EudraCT Number:	2020-004942-12
Sponsor's Protocol Code Number:	Protokol_MFCN_10102020
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:	2020-10-13
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

2020-004942-12

A.3

Full title of the trial

Selective ultrasound-guided nerve block of the medial femoral cutaneous nerve in healthy volunteers

Selektiv ultralydvejledt nerveblokade af den mediale kutane gren 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 and medial side of the knee

Et studie som undersøger effekten af at indsprøjte lokalbedøvelse på forsiden af låret under ultralydsvejledning for at bedøve den nervegren, som forsyner huden på for- og indersiden af knæet

A.4.1

Sponsor's protocol code number

Protokol_MFCN_10102020

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	Sallingfonden
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	Erling Jacobsens gade 67
B.5.3.2	Town/ city	Risskov
B.5.3.3	Post code	8240
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+4560651087
B.5.6	E-mail	siskabjoern@clin.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	Marcain-adrenalin
D.2.1.1.2	Name of the Marketing Authorisation holder	Aspen
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	Bupivacain-adrenalin
D.3.4	Pharmaceutical form	Solution for 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.3.9.1	CAS number	14252-80-3
D.3.9.3	Other descriptive name	BUPIVACAINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB00902MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	51-43-4
D.3.9.3	Other descriptive name	ADRENALINE TARTRATE PH. EUR.
D.3.9.4	EV Substance Code	SUB176490
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(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 incisions after total knee arthroplasty (TKA).
The area anesthetized by new nerve block techniques anesthetizing the medial femoral cutaneous nerve are investigated in healthy volunteers to see if the relevant area around the surgical incision sites are anesthetized.

Smerter fra den kirurgiske incision efter total knæalloplastik (TKA). Det område, som anæsteseres ved en ny
nerveblokadeteknik, som skal anæstesere den mediale 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	21.1
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	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.1.2 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 anesthesia of the "gap" (non-anesthetized area) on the surgical incision used for TKA after nerve block of the anterior branch from the medial femoral cutaneous nerve (MFCN) compared to the posterior branch of the MFCN.

Undersøgelsens primære formål er ved prospektiv dataindsamling i raske forsøgspersoner at undersøge succesrate for dækning med anæstesi af ”gap” (ikke-anæsteseret område) på den kirurgiske midtlinje-incision efter blokade af den anteriore gren fra MFCN sammenlignet med den posteriore gren fra MFCN.

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 and of the medial parapatellar incision. Evaluation of the contributions from the different nerves in covering the midline skin incision and the medial parapatellar incision. Evaluation of the anesthetized areas after blockade of the MFCN and of the anterior branch of the MFCN (MFCNant) and posterior branch (MFCNpost). Furthermore muscle strength is evaluated from before to after placement of the blocks. Other secondary objectives include the time used for placement of the MFCN block as well as MFCNant block and an evaluation of the discomfort during nerve block placement.

Undersøgelsens sekundære formål omfatter succesrate for dækning af hele midtlinje-incisionen samt dækning af området for den mediale parapatellare incision. Derudover vurderes hvilke nerver, som bidrager til dækning af hhv. midtlinje-incisionen og området for den mediale parapatellare incision. Desuden estimeres arealerne af de anæsteserede hudområder efter hhv. MFCN, MFCNant samt MFCNpost blokade.
Desuden er undersøgelsens formål at vurdere ændringen i muskelstyrke fra før til efter anlæggelse af de forskellige nerveblokader. Andre sekundære effektmål inkluderer anlæggelsestid for MFCN og MFCNant blokade samt en vurdering af ubehaget ved anlæggelse af disse.

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
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
Daily use of medicine except oral contraceptives

Manglende evne til samarbejde
Manglende danskkundskaber
Kendt neuropati i underekstremiteter
Infektion i området omkring indstiksstederne for nerveblokaderne
Overvægt (Body Mass Index, BMI) > 28 kg/m2)
Vægt < 60 kg
Graviditet
Overfølsomhed for de anvendte lægemidler
Dagligt forbrug af medicin fraset oral antikonception

E.5 End points

E.5.1

Primary end point(s)

Success rate of anesthesia of the gap (non-anesthetized area) on the midline incision used for TKA after block of the anterior branch of the MFCN compared to the posterior branch of the MFCN.

Succesrate for dækning med anæstesi af gap på den kirurgiske midtlinje-incision efter blokade af den anteriore gren fra MFCN sammenlignet med blokade af den posteriore gren fra MFCN.

E.5.1.1

Timepoint(s) of evaluation of this end point

Cutaneous anesthesia is evaluated using pin-prick testing after placement of the last nerve blocks (nerve block round 4)

Kutan anæstesi vurderes med pinprick efter anlæggelse af den sidste nerveblokade (nerveblokaderunde 4)

E.5.2

Secondary end point(s)

1. Success rate of anesthesia of the entire midline incision after block of the anterior branch from MFCN compared to the posterior.
2. Success rate of anesthesia of the gap on the midline skin incision after block of the MFCN (both branches)
3. Which nerves contribute to anesthesia of the midlinje incision
4. Success rate of anesthesia of the entire parapatellar incision after block of the anterior branch of the MFCN compared to the posterior branch of the MFCN.
5. Success rate of anesthesia of the entire parapatellar incision after block of the MFCN (both branches)
6. Hvis nerves contribute to anesthesia of the patapatellar incision
7. Anesthetized area after MFCN block (both branches)
8. Anesthetized area after block of the anterior branch of MFCN
9. Anesthetized area after block of the posterior branch of MFCN
10. Additional anesthetized area after MFCNant block in addition to MFCN block.
11. Change in muscle strength of the quadriceps muscle from baseline to after block of the intermediate femoral cutaneous nerves (IFCN)
12. Change in muscle strength of the quadriceps muscle from after IFCN block to after saphenus nerve block.
13. Change in muscle strength of the quadriceps muscle from after saphenus block placement to after MFCN/MFCNant block
14. Time spent on MFCN block placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle.
15. Time spent on MFCNant block placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle.
16. Discomfort during placement of MFCN block (NRS 0-10)
17. Discomfort during placement of MFCNant block (NRS 0-10)

1. Succesrate for dækning med anæstesi af hele midtlinje-incisionen efter blokade af den anteriore gren fra MFCN sammenlignet med blokade af den posteriore gren fra MFCN
2. Succesrate for dækning med anæstesi af gap på den kirurgiske midtlinje-incision efter blokade af MFCN (dvs. begge grene)
3. Hvilke nerver som bidrager til dækning af midtlinje-incisionen
4. Succesrate for dækning af hele den parapatellare incision efter blokade af den anteriore gren fra MFCN sammenlignet med blokade af den posteriore gren fra MFCN
5. Succesrate for dækning med anæstesi af den mediale parapatellare incision efter blokade af MFCN (dvs. begge grene)
6. Hvilke nerver som bidrager til dækning af den parapatellare incision
7. Areal af det anæsteserede område efter MFCNB
8. Areal af det anæsteserede område efter MFCNant blokade
9. Areal af det anæsteserede område efter MFCNpost blokade
10. Ekstra anæsteseret areal ved tillæg af MFCNant blokade til MFCN blokade
11. Ændring i muskelstyrke af m. quadriceps fra baseline til efter blokade af de intermediære kutane femoralisgrene (IFCN).
12. Ændring i muskelstyrke af m. quadriceps fra efter anlæggelse af IFCNB til efter anlæggelse af saphenusblokade
13. Ændring i muskelstyrke af m. quadriceps fra efter anlæggelse af saphenusblokade til efter anlæggelse af MFCN/MFCNant blokade
14. Tidsforbrug til MFCN blokadeanlæggelse. Tidsforbruget er defineret ved tiden fra start af ultralydscanning til udtrækning af blokadenålen
15. Tidsforbrug til MFCNant blokadeanlæggelse. Tidsforbruget er defineret ved tiden fra start af ultralydscanning til udtrækning af blokadenålen
16. Ubehaget under anlæggelse af MFCN blokade (NRS-skala fra 0 til 10)
17. Ubehaget under anlæggelse af MFCNant blokade (NRS-skala fra 0 til 10)

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 nerve blocks (IFCNB), after saphenous nerve block and after MFCN/MFCN ant block (nerve block round 3 and 4).

Sensation to pin-prick (cutaneous anesthesia): evaluated at baseline (right after inclusion before any block placement), after IFCN block, after saphenous nerve block and after MFCN/MFCNant block (nerve block round 3 and 4).

Discomfort during block placement: Evaluated after placement of MFCN/MFCNant block.

Muskelstyrke: evalueres ved baseline (lige efter inklusion, før anlæggelse af blokader), efter anlæggelse af IFCN blokade, efter anlæggelse af saphenusblokade og efter MFCN/MFCNant blokade (nerveblokaderunde 3 og 4).

Sensorisk test med pin-prick (kutan anæstesi): evalueres ved baseline (lige efter inklusion, før anlæggelse af blokader), efter anlæggelse af IFCN blokade, efter anlæggelse af saphenusblokade og efter MFCN/MFCNant blokade (nerveblokaderunde 3 og 4)

Ubehag under blokadeanlæggelse: evalueres efter anlægelse af MFCN/MFCNant blokade.

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

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

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)

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 2020-10-13.

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.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

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

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

2020-11-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-12-13

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