Clinical Trials Register

Summary
EudraCT Number:	2013-005346-10
Sponsor's Protocol Code Number:	AUH-TFB-SR
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:	2014-08-22
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

2013-005346-10

A.3

Full title of the trial

Shamrock versus Lumbar Ultrasound Trident – Ultrasound guided block of the lumbar plexus

Shamrock versus Lumbar Ultrasound Trident – Ultralydvejledt blokade af plexus lumbalis – Metodestudie

A.3.1

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

Shamrock versus Lumbar Ultrasound Trident – Ultrasound guided block of the lumbar nervous plexus

Shamrock versus Lumbar Ultrasound Trident – Ultralydvejledt blokade af lænderegionens nervefletværk – Metodestudie

A.4.1

Sponsor's protocol code number

AUH-TFB-SR

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	Thomas Fichtner Bendtsen
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	The A. P. Møller Foundation
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Oslo University Hospital
B.4.2	Country	Norway
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Thomas Fichtner Bendtsen
B.5.2	Functional name of contact point	Clinical Trial Info – Shamrock
B.5.3	Address:
B.5.3.1	Street Address	Dep. of Anaesthesiology and Intensive Care Medicine, Aarhus University Hospital, Nørrebrogade 44
B.5.3.2	Town/ city	Aarhus C
B.5.3.3	Post code	DK-8000
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+4551542997
B.5.6	E-mail	tfb@dadlnet.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	Lidokain-adrenalin SAD
D.2.1.1.2	Name of the Marketing Authorisation holder	Amgros I/S
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.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Perineural use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lidocaine
D.3.9.3	Other descriptive name	LIDOCAINE
D.3.9.4	EV Substance Code	SUB08507MIG
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Adrenaline
D.3.9.1	CAS number	55-31-2
D.3.9.3	Other descriptive name	EPINEPHRINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB01912MIG
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
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	Dotarem
D.2.1.1.2	Name of the Marketing Authorisation holder	GUERBET – Vicare Medical A/S
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.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Perineural use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GADOTERIC ACID
D.3.9.1	CAS number	72573-82-1
D.3.9.4	EV Substance Code	SUB07865MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/ml millimole(s)/millilitre
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

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

Hip surgery anaesthesia and peri-operative hip pain therapy.

Bedøvelse til hoftekirurgi og perioperativ behandling af hoftesmerter.

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	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10054710
E.1.2	Term	Postoperative hip pain
E.1.2	System Organ Class	100000004863

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	PT
E.1.2	Classification code	10051060
E.1.2	Term	Hip surgery
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 main objective of the trial is to complete a double-blinded randomized controlled trial of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident technique by estimating the time for performance of lumbar plexus block in healthy volunteers.

Det primære formål med projektet er at gennemføre en dobbeltblindet randomiseret kontrolleret undersøgelse af plexus lumbalis blokade med Shamrock-teknikken versus Lumbar Ultrasound Trident-teknikken ved at estimere tiden for anlæggelse af plexus lumbalis blokade i raske frivillige forsøgspersoner.

E.2.2

Secondary objectives of the trial

The secondary objective of the trial is to estimate:
• Number of needle injections
• Discomfort during block injection
• Plasma lidocaine
• Mean arterial blood pressure
• Sensory block of the dermatomes T8-S3 and the terminal lumbar plexus nerves innervation
• Motor block of the femoral nerve, the obturator nerve, the hip abductor muscles and the hamstring muscles
• Success rate of lumbar plexus block
• Distribution of local anaesthetics epidurally and surrounding the lumbar plexus nerves with MRI after lumbar plexus block
• Cost-effectiveness for lumbar plexus block
for the Shamrock-technique compared to the Lumbar Ultrasound Trident-technique in healthy volunteers.

Det sekundære formål med projektet er at estimere:
• Antallet af nåleføringer
• Ubehag ved blokadeanlæggelse
• Plasma lidokain
• Middelarterielt blodtryk
• Sensorisk blokade af dermatomerne T8-S3 og terminale nerver fra plexus lumbalis
• Motorisk blokade af nervus femoralis, nervus obturatorius, hofteabduktorer og hasemuskler
• Bloksucces efter blokadeanlæggelse
• Spredningen af lokalanalgetikum epiduralt samt omkring de lumbale nerver vurderet med MRI efter blokadeanlæggelse
• Cost-effectiveness for plexus lumbalis blokade
for Shamrock-teknikken sammenlignet med Lumbar Ultrasound Trident-teknikken i raske frivillige forsøgspersoner.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male.
• Age ≥ 18 years.
• Volunteers who have given their written and oral informed consent to participate in the study after fully understanding the content and the limitations of the protocol.
• Normal healthy person (American Society of Anesthesiology Classification, ASA I).

• Alder ≥ 18 år.
• Forsøgspersoner som har givet deres skriftlige og mundtlige informerede samtykke til at deltage i undersøgelsen efter at have forstået protokollens indhold og begrænsninger fuldt ud.
• Normal rask person (American Society of Anesthesiology Classification, ASA I).

E.4

Principal exclusion criteria

• Volunteers not able to cooperate for the study.
• Volunteers not able to understand Danish.
• Daily use of analgesics.
• Allergy against the medicines used in the study.
• Drug abuse – according to the investigator's judgement
• Alcohol consumption larger than the recommendations of the Danish National Board of Health
• Volunteers in who nerve blocks are not possible due to technical reasons
• Volunteers who fulfil any contraindiation for MRI including claustrophobia.
• Volunteers who are incompetents, eg. surrogate consent is not accepted.

• Forsøgspersoner som ikke kan samarbejde til undersøgelsen.
• Forsøgspersoner som ikke forstår og taler dansk.
• Dagligt forbrug af analgetikum.
• Allergi over for de i undersøgelsen anvendte stoffer.
• Medicinmisbrug – efter investigators skøn.
• Større alkoholforbrug end Sundhedsstyrelsens retningslinjer, dvs. > 14 genstande ugentligt for mænd.
• Forsøgspersoner hos hvem det som følge af tekniske forhold ikke er muligt, at anlægge blokaderne.
• Forsøgsperson hos hvem der er kontraindikation for MRI skanning inkl. klaustrofobi
• Inhabile patienter, dvs., at der ikke kan benyttes stedfortrædende samtykke.

E.5 End points

E.5.1

Primary end point(s)

Time for performance of lumbar plexus block in seconds from placement of the ultrasound transducer on the skin until the block needle is pulled out after injection of local anaesthetics.

Anlæggelsestiden i sekunder for plexus lumbalis blokade fra anbringelse af ultralydtransduceren på huden indtil blokadenålen er trukket ud igen efter injektion af lokalanalgetikum.

E.5.1.1

Timepoint(s) of evaluation of this end point

When the block needle is pulled out after injection of local anaesthetics.

Når blokadenålen er trukket ud igen efter injektion af lokalanalgetikum.

E.5.2

Secondary end point(s)

• Number of needle feeds (retraction of needle followed by new feed of the needle disregarding of number of skin puntures).
• Discomfort during block placement measured with Numeric Rating Scale (NRS 0-10)
• Plasma lidocaine
• Mean arterial pressure
• Cost-effectiveness estimated as extra expense per successful nerve block (incremental cost-effectiveness ratio, ICER)
• Sensor block (cold, warm, touch, pain) of the dermatomes T8–S3 and of the femoral nerve and the lateral femoral cutaneous nerve
• Motor block of the femoral nerve (knee extension), the obturator nerve (hip adduction), the superior gluteal nerve (hip abduction) and the sciatic nerve (knee flexion) estimated as active resistance against movement of the relevant joint and with sphygmomanometer of the relevant joint as maximal voluntary isometric contraction with dynamometer (mmHg).
• Success rate defined as motor block of the femoral nerve (knee extension) and the obturator nerve (hip adduction) and reduced sensory of the lateral femoral cutaneous nerve (middle of the lateral side of the thigh)
• Success rate as defined above after lumbar plexus block with the Shamrock-technique for motor response on electrical nerve stimulation above respectively below 0,5 mA.
• Epidural spread of local analgesics with contrast estimated with T1-, T2- and DWI-weighted MRI scanning.
• Perineural spread of local analgesics with contrast estimated with T1-, T2- and DWI-weighted MRI scanning.

• Antallet af nålefremføringer (tilbagetrækning efterfulgt af ny fremføring af nålen uanset antal hudindstik).
• Ubehag ved blokanlæggelse (NRS 0-10).
• Plasma-lidokain.
• Middel arteriel blodtryk.
• Cost-effectiveness estimeret som inkrementel cost-effectiveness ratio (ICER) estimeret som ekstra udgift per ekstra succesfuld nerveblokade.
• Sensorisk blokade (kulde, varme, berøring, smerte) af hvert af dermatomerne T8–S3.
• Sensorisk blokade (kulde, varme, berøring, smerte) af nervus femoralis og nervus cutaneus femoris lateralis.
• Motorisk blokade af knæekstension (nervus femoralis), hofteadduktion (nervus obturatorius), hofteabduktion (n. glutealis superior) og knæfleksion (n. ischiadicus) vurderet med aktiv resistens mod bevægelse af det relevante led og med sphygmomanometri af det relevante led som maksimum voluntær isometrisk kontraktion med dynamometer (mmHg).
• Succesrate (SR) defineret som motorisk blokade af n. femoralis og n. obturatorius og reduceret sensorik af n. cutaneus femoris lateralis.
• Succesrate som ovenfor defineret efter nerveblokade anlagt med Shamrock metoden for motorisk respons på elektrisk nervestimulation henholdsvis over eller under 0,5 mA.
• Epidural spredning af lokalanalgetikum med kontrast vurderet med T1-, T2- og DWI-vægtet MRI skanning.
• Perineural spredning af lokalanalgetikum med kontrast vurderet med T1-, T2- og DWI-vægtet MRI skanning.

E.5.2.1

Timepoint(s) of evaluation of this end point

• Number of needles feeds: immediately after block placement.
• Discomfort during block placement: immediately after block placement.
• Plasma lidocaine: 0, 5, 10, 20, 40, 60 and 90 minutes after block placement.
• Mean arterial pressure: 5 minutes after block placement.
• Cost-effectiveness: after the trial is finished.
• Sensor block: 30 minutes after block placement.
• Motor block: 40 minutes after block placement.
• Success rate: 30 minutes after block placement.
• Epidural spread of local analgesics with contrast: 10-30 minutes after block placement.
• Perineural spread og local analgesics with contrast: 10-30 minutes after block placement.

• Antallet af nålefremføringer: umiddelbart efter blokadeanlæggelse.
• Ubehag ved blokanlæggelse: umiddelbart efter blokadeanlæggelse.
• Plasma lidokain: 0, 5, 10, 20, 40, 60 og 90 minutter efter blokadeanlæggelse.
• Middel arteriel blodtryk: 5 minutter efter blokanlæggelse.
• Cost-effectiveness: efter forsøget er afsluttet.
• Sensorisk blokade: 30 minutter efter blokadeanlæggelse.
• Motorisk blokade: 40 minutter efter blokadeanlæggelse.
• Succesrate: 30 minutter efter blokadeanlæggelse.
• Epidural spredning af lokalanalgetikum med kontrast: 10-30 minutter efter blokadeanlæggelse.
• Perineural spredning af lokalanalgetikum med kontrast: 10-30 minutter efter blokadeanlæggelse.

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Cost-effectiveness of the Shamrock-technique and the Lumbar Ultrasound Trident-technique, respectively.

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

E.8.1.6

Cross over

Yes

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

En anden teknik til at placere den samme medicin.

Another technique to place the same medicinal product.

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

Yes

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

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)

None.

Ej relevant.

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

2014-11-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-08-07

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

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