Clinical Trials Register

Summary
EudraCT Number:	2015-003498-13
Sponsor's Protocol Code Number:	HIP/FUSION#1
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2016-01-29
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

2015-003498-13

A.3

Full title of the trial

Surgical anesthesia for elective hip surgery - hemodynamic effect of lumbosacral plexus blockade compared to continuous spinal anesthesia

Kirurgisk anæstesi til elektiv hoftekirurgi – hæmodynamisk påvirkning ved ultralydsvejledt lumbosacral plexusblokade sammenlignet med titreret spinalanæstesi

A.3.1

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

Anesthesia for planned hip surgery - comparison of the effect on heart and blood circulation from peripheral nerve blockade and spinal anesthesia

Bedøvelse til planlagt hoftekirurgi - sammenligning af påvirkningen på hjerte og blodkredsløb ved perifer nerveblokade og rygmarvsbedøvelse

A.4.1

Sponsor's protocol code number

HIP/FUSION#1

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02544269

A.5.4

Other Identifiers

Name:	Local health research ethics committee no.	Number:	51392
Name:	Danish data protection agency no.	Number:	2015-57-0002

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	Institut for Klinisk Medicin, Aarhus Universitet
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	A.P. Møller og Hustru Chastine Mc-Kinney Møllers Fond til almene Formaal
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Kong Christian den Tiendes Fond
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Graduate School of Health, Aarhus University
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	Institut for Klinisk Medicin, Aarhus Universitet
B.5.2	Functional name of contact point	Niels Dalsgaard Nielsen
B.5.3	Address:
B.5.3.1	Street Address	Noerrebrogade 44, building 1C, 1st floor
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	+452283 8334
B.5.6	E-mail	nielsdn@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 Spinal
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca
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	Intrathecal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Bupivacaine
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.3.10.2	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	Ropivacain "Fresenius Kabi"
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi
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	Perineural use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ropivacaine
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	7.5
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	Injection
D.8.4	Route of administration of the placebo	Perineural use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Injection
D.8.4	Route of administration of the placebo	Intrathecal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

No specific medical condition is investigated. The objective of the investigation is to compare two methods for surgical anesthesia for total hip replacement.

Der undersøges ikke en specifik medicinsk tilstand. Studiets formål er at sammenligne to metoder til kirurgisk anæstesi til hoftealloplastik.

E.1.1.1

Medical condition in easily understood language

No specific medical condition is investigated. The objective of the investigation is to compare two methods for anesthesia for major hip surgery.

Der undersøges ikke en bestemt sygdom eller tilstand. Studiets formål er at sammenligne to metoder til bedøvelse til operation med stor hoftekirurgi.

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	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10068084
E.1.2	Term	Anesthesia procedure
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Comparison of the hemodynamic effect of lumbosacral plexus blockade versus continuous spinal anesthesia.

Sammenligning af den hæmodynamiske effekt af lumbosakral plexusblokade og kontinuerlig spinalanæstesi.

E.2.2

Secondary objectives of the trial

Comparison of time for anesthesia performance, succes rate for surgical anesthesia, plasma concentrations of ropivacaine and lactate following anesthesia induction, cumulated dose of sedative administrated during surgery, cumulated dose of opioid after surgery, surgeons satisfaction with anesthesia and patients worst pain during surgery.

Sammenigning af tid for blokadeanlæggelse, succes rate for kirurgisk anæstesi, plasmakoncentration af ropivacain og laktat efter induktion af anæstesi, kumuleret peroperativ dosis af sedativa, kumuleret postoperativ dosis af opioider, kirurgens tilfredshed med anæstesien, patientens værste smerter under operationen.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients for total hip replacement under spinal anesthesia at Silkeborg Regional Hospital, Denmark
Age ≥ 50 years
American Society of Anesthesiologists physical status classification score I-III
Informed consent

Patienter indstillet til hoftealloplastik i spinalanæstesi på Regionshospitalet Silkeborg
Alder ≥ 50 år
American Society of Anesthesiologists physical status classification score I-III
Informeret samtykke

E.4

Principal exclusion criteria

Lack of ability to cooperate
Lack of ability to speak Danish
Cronic opioid demanding pain not originating from the hip area
Previous major back surgery
Previous venous tromboembolic event
Severe cardiopulmonary dissease (NYHA class 4)
Severe untreated hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 110 mm Hg)
Obesity (BMI > 35 kg/m^2)
Active treatment with amiodarone
Active treatment with verapamil
Allergy towards at least one IMP

Manglende evne til korporation
Manglende danskegenskaber
Kroniske opioidkrævende smerter, der ikke stammer fra hofteregionen
Tidligere venøs tromboemboli
Tidligere større lumbal rygkirurgi
Svær kardiopulmonal sygdom sv.t. NYHA IV
Svær ubehandlet hypertension (Systolisk blodtryk > 160 mmHg eller diastolisk blodtryk > 110 mmHg)
Fedme (BMI > 35 kg/m^2)
Aktuel behandling med amiodaron
Aktuel behandling med verapamil
Overfølsomhed overfor de anvendte præparater

E.5 End points

E.5.1

Primary end point(s)

Significant reduction in anesthesia impact on cardiac output.

Signifikant reduktion i anæstesiens påvirkning af cardiac output.

E.5.1.1

Timepoint(s) of evaluation of this end point

Every 5th minute after nerve blockade performance for 60 minutes.

Hvert 5. minut efter anlæggelse af nerveblokader i 60 minutter.

E.5.2

Secondary end point(s)

Time for nerve blockade performance
Success rate of surgical anesthesia
Change of cardiac stroke volume
Change of systemic vascular resistance
Change of mean arterial pressure
Change of central venous oxygen saturation
Maximum plasma ropivacaine concentration
Change of plasma lactate concentration
Cumulated peroperative dose of propofol
Cumulated peroperative dose of opioids
Cumulated postoperative dose of opioids
Time from end of operation to first dose of opioid
Surgeons satisfaction with anesthesia (numeric rating scale)
Patients worst pain during surgery (numeric rating scale)

Tid for blokadeanlæggelse
Succesrate for blokadeanlæggelse
Ændring af SV
Ændring af SVR
Ændring af MAP
Ændring af SCVO2
Maksimal værdi af plasma-ropivacain
Ændring af plasma-laktat under observationsperioden
Summeret peroperativ propofoldosis
Postoperativt opioidbehov
Tid fra operationens afslutning til første dosis dosis opioid
Kirurgens tilfredshed med anæstesien (numerisk vurderingsskala)
Patientens peroperative smertescore (numerisk vurderingsskala)

E.5.2.1

Timepoint(s) of evaluation of this end point

Time for nerve blockade performance: Immediately after nerve blockade performance
Success rate of surgical anesthesia: 40 minutes after nerve blockade performance
Cardiovascular changes: Every 5th minute after nerve blockade performance for 60 minutes
Plasma ropivacaine concentration: 20, 40, 60, 80, 100, 120, 140 and 160 minutes after nerve blockade performance
Plasma lactate concentration: 0, 30 and 60 minutes after nerve blockade performance
Peroperative propofol and opioid doses as well as surgeons satisfaction with anesthesia: As the patient leaves the operating room
Patients pain during surgery: 1 hour after surgery
Postoperative opioid dose and time-to-first opioid-dose: 24 hours after blockade performance

Tid for blokadeanlæggelse: Umiddelbart efter anlæggelse af nerveblokader
Succesrate for blokadeanlæggelse: 40 minuter efter anlæggelse af nerveblokader
Kardiovaskulære ændringer: Hvert 5. minut efter anlæggelse af nerveblokader i 60 minutter.
Plasma-ropivacain-koncentration: 20, 40, 60, 80, 100, 120, 140 og 160 min efter anlæggelse af nerveblokader
Plasma-laktat-koncentratione: 0, 30 og 60 min efter anlæggelse af nerveblokader
Peroperativ propofol- og opioiddosis såvel som kirurgens tilfredshed med anæstesien: Når patienten forlader operationsstuen
Postoperativt opioidbehov og tid til første opioiddoses: 24 timer efter blokadeanlæggelse
Patientens peroperative smerte: 1 time efter operationen

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

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)

Yes

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

Last visit of last patient.

Efter besøg af sidste patient

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 2016-01-29.

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
Comment regarding fields F.1.2.1 and F.1.3.1: The total number of subjects in this study is 36 persons on or above the age of 18. The correct value for each of the above mentioned fields should therefore be "0-36".

Ingen
Kommentar til felterne F.1.2.1 og F.1.3.1: The totale antal forsøgspersoner i studiet er 36 personer på eller over 18 år. Den korrekte værdi for de ovennævnte felter burde derfor være "0-36".

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Center for Planned Surgery, Silkeborg Regional Hospital
G.4.3.4	Network Country	Denmark

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-03-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-02-25

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2017-02-24

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