Clinical Trials Register

Summary
EudraCT Number:	2022-000093-25
Sponsor's Protocol Code Number:	01_20012022
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-01-31
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

Denmark - DHMA

A.2

EudraCT number

2022-000093-25

A.3

Full title of the trial

The effect of lateral pectoral nerve block in combination with interscalene nerve block on opioid consumption and pain on awake shoulder arthroscopy patients
- A feasibility study

Effekten af lateral pectoralis nerve blokade i kombination med skalenerblokade på opioidforbrug og smerte ved vågen skulderartroskopi
- et feasibility studie

A.3.1

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

The effect of lateral pectoral nerve block in combination with interscalene nerve block on opioid consumption and pain on awake shoulder arthroscopy patients

Effekten af lateral pectoralis nerve blokade i kombination med skalenerblokade på opioidforbrug og smerte ved vågen kikkertoperation af skulderen

A.4.1

Sponsor's protocol code number

01_20012022

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	Horsens Regional Hospital
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 Hospital
B.5.2	Functional name of contact point	Thomas Fichtner Bendtsen
B.5.3	Address:
B.5.3.1	Street Address	Palle Juul-Jensens Blvd. 165
B.5.3.2	Town/ city	Aarhus N
B.5.3.3	Post code	8200
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	Comparator
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 Pharma
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	Marcain-Adrenalin
D.3.4	Pharmaceutical form	Concentrate and solvent for 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.3.8	INN - Proposed INN	Bupivacaine
D.3.9.1	CAS number	2180-92-9
D.3.9.4	EV Substance Code	SUB05983MIG
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	EPINEPHRINE
D.3.9.1	CAS number	51-43-4
D.3.9.4	EV Substance Code	SUB06568MIG
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.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	Concentrate for solution for injection/infusion
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

Peri- and postoperative pain after shoulder arthroscopy

Peri- og postoperative smerte ved skulderartroskopi

E.1.1.1

Medical condition in easily understood language

Pain during and after shoulder arthroscopy

Smerter under og efter kikkertoperation af skulderen

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	10077421
E.1.2	Term	Shoulder arthroscopy
E.1.2	System Organ Class	100000004848

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 purpose of this trial is to asses the effect of preoperative placed active or placebo lateral pectoral nerve block in combination with active interscalene nerve block on awake patients during shoulder arthroscopy.
The primary objective of the study is to investigate perioperative opioid consumption

Formålet er at vurdere analgetisk effekt af præoperativt anlagt aktiv eller placebo lateral pectoral nerveblokade i kombination med aktiv skalenerblokade på vågne patienter der får foretaget skulderartroskopi.
Forsøgets primære mål er at undersøge det peroperative opioidforbrug

E.2.2

Secondary objectives of the trial

The secondary objective is to investigate the quality of the anaesthesia according to the orthopedic surgeon

Det sekundære mål er, at undersøge den ortopædkirurgiske tilfredshed med anæstesien.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Set for elective shoulder arthroscopy by one single orthopedic surgeon
• Planned acromioclavikular decompression
• Planned awake surgery anesthetized by an interscalene nerve block
• ASA I-III
• Patient ≥ 18 years
• Informed consent

• Indstillet til elektiv ambulant vågen skulderkirurgi ved en og samme ortopædkirurg.
• Planlagt acromioclavikulær resektion
• Planlagt vågen kirurgi vha. anæstesiologisk anlagt skalenerblokade
• ASA I-III
• Patient ≥ 18 år
• Informeret samtykke

E.4

Principal exclusion criteria

• Inability to cooperate
• Unable to speak and/or understand danish or other types of communication problems
• Other major planned operative procedures planned during this operation (Bankart, cuff-operations etc.)
• Allergy to local analgesics in the study (Marcain + adrenaline)
• Lack of tolerance of Fentanyl
• Chronic pain with daily opioid consumption (dosed > x 1 day)
• Chronic pain treated with gabapentin, pregabalin, tricyclic antidepressants, opioid antagonists or SNRI
• Treatment with antipsychotics
• The patient is unsuitable for awake surgery
• Known abuse of alcohol, drugs or medicine
• Previous shoulder surgery on the planned side for this shoulder arthroscopy
• Previous participation in this study
• Pregnancy

• Manglende evne til at samarbejde
• Manglende kundskaber til at tale og forstå dansk eller andre former for kommunikationsproblemer
• Andre former for større ambulant skulderkirurgi planlagt foretaget under samme operation (Bankart, Cuff-operationer)
• Allergi over for anvendte lokalanalgetika i undersøgelsen (Marcain + Adrenalin)
• Manglende tolerance over for Fentanyl angivet af patienten ved forespørgsel
• Kroniske smerter med dagligt opioidforbrug (doseret > x 1dgl)
• Kroniske smerter og i behandling med gabapentin, pregabalin, tricykliske antidepressiva, opioidantagonoister eller SNRI præparater
• Behandling med antipsykotika
• Patienten vurderes uegnet til vågen skulderkirurgi af anæstesilæge
• Misbrug af alkohol, euforiserende stoffer eller medicin.
• Tidligere skulderopereret på den planlagte side for denne operation
• Tidligere deltagelse i dette studie (ved operation på modsatte side)
• Graviditet. Alle kvinder udspørges om graviditet i.f.m. gennemgang af eksklusionskriterier. Alle kvinder uden verificeret menopause > 1 år u-HCG testes på operationsdagen før inklusion

E.5 End points

E.5.1

Primary end point(s)

• Opioidconsumption perioperative during awake ambulatory awake shoulder arthroscopy on patients anesthetized with an interscalene nerve block with active or placebo lateral pectoral nerve block

• Opioidforbrug peroperativt under elektiv ambulant vågen skulderartroskopi af patienter anæsteseret med skalenerblokade og med aktiv eller placebo lateral pectoral nerve blokade.

E.5.1.1

Timepoint(s) of evaluation of this end point

Perioperatively

Perioperativt

E.5.2

Secondary end point(s)

• Orthopaedic surgeon evaluation of anaesthesia (good/medium/poor)
• Patient-Experienced pain score perioperatively (NRS 0-10, where 0 is no pain and 10 the worst possible pain)
• Total number of injections and consumption of opioid (Fentanyl) perioperatively
• Need for additional local anaesthetics injected in the AC joint by the orthopaedic surgeon peroperatively
• Total morphine consumption in PACU
• The force of the Pectoral muscles on the planned operated upper limb is tested with a dynamometer before the lateral pectoral nerve blockade is placed and again 20-30 minutes after and before the placing of the interscalene nerve block.

• Ortopædkirurg vurdering af anæstesi (god/middel/dårlig)
• Patientoplevet smertescore (NRS 0-10, hvor 0 er ingen smerte og 10 den værst tænkelige smerte) i skulderen peroperativt.
• Samlet antal injektioner og forbrug af opioid (Fentanyl) peroperativt
• Behov for supplerende lokalanæstesi anlagt af ortopædkirurg i AC leddet peroperativt.
• Samlet opioidforbrug i Opvågningsafsnittet (PACU).
• Pectoralis muskelkraft på den planlagt opererede overekstremitet testes med et dynamometer, før der anlægges lateral pectoral nerveblokade og igen efter 20-30 min og inden anlæggelse af skalenerblokade.

E.5.2.1

Timepoint(s) of evaluation of this end point

Assessed perioperatively and postoperative in PACU

Vurderes perioperativt og postoperativt i oberservationsafsnittet

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

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

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)

Yes

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

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 2022-01-31.

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

Yes

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

2022-03-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-05-05

P. End of Trial
P.	End of Trial Status	Ongoing

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