Clinical Trials Register

Summary
EudraCT Number:	2017-001714-29
Sponsor's Protocol Code Number:	290975
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-06-14
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

Finland - Fimea

A.2

EudraCT number

2017-001714-29

A.3

Full title of the trial

Influence of epidural analgesia on opioid consumption and patients recovery after laparoskopic colorectal surgery.

Epiduraalipuudutuksen vaikutus opiodikipulääkkeiden tarpeeseen ja potilaiden toipumiseen laparoskooppisen kolon-kirurgian jälkeen

A.3.1

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

Influence of epidural analgesia on opioid consumption and patients recovery after bowel surgery.

A.3.2

Name or abbreviated title of the trial where available

EPRAL

A.4.1

Sponsor's protocol code number

290975

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	Helsinki University hospital
B.1.3.4	Country	Finland
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	No
B.4.2	Country	Finland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Helsinki University hospital
B.5.2	Functional name of contact point	Alexey Schramko
B.5.3	Address:
B.5.3.1	Street Address	Turuntie 150
B.5.3.2	Town/ city	Jorvi
B.5.3.3	Post code	00029 HUS
B.5.3.4	Country	Finland
B.5.4	Telephone number	+358504270610
B.5.6	E-mail	aschramko@hotmail.com

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 Orion 2 mg/ml inf. liuos
D.2.1.1.2	Name of the Marketing Authorisation holder	Orion
D.2.1.2	Country which granted the Marketing Authorisation	Finland
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 Orion 2 mg/ml inf. liuos
D.3.2	Product code	N01BB09
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	Epidural use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ROPIVACAINE HYDROCHLORIDE
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	2
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

Compare epidural and conventional pain treatment after laparoskopic colorectal surgery.

Tutkimuksen tavoitteena on verrata epiduraalipuudutusta ja perinteistä kivun hoitoa kolonkirurgisten potilaiden postoperatiivisessa toipumisessa.

E.1.1.1

Medical condition in easily understood language

Compare epidural and conventional pain treatment after laparoskopic colorectal surgery.

Tutkimuksen tavoitteena on verrata epiduraalipuudutusta ja perinteistä kivun hoitoa kolonkirurgisten potilaiden postoperatiivisessa toipumisessa.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary outcome is the opioid consumption 48h postoperatively.

Ensisijainen lopputulosmuuttuja on ryhmien välinen ero opioidin kulutuksessa 0- 48 tuntia leikkauksen jälkeen.

E.2.2

Secondary objectives of the trial

Secondary outcomes: pain intensity, initiation of the bowel action, intraoperative fluid balance, postoperative complications, ward-stay time. Additionally, we will compare the efficacy of pain treatments in two subgroups: left- and right hemicolonectomy.

Sekundaariset lopputulosmuuttujat ovat kipu NRS-asteikolla, potilaiden postoperatiivinen suoliston toiminnan käynnistyminen (monenako postoperatiivisena päivänä leikkauksen jälkeen) intraoperatiivinen nestetasapaino, postoperatiiviset komplikaatiot (kliinisesti todettu leikkaushaavan infektio, leikkauksen jälkeinen keuhkokuume, suoliiskemia, uusintaleikkaus saman hoitojakson aikana, sairaala re-admissio), sekä sairaalassaoloaika (monenako postoperatiivisena päivän potilas on lähtenyt kotiin). Lisäksi tutkimuksen etukäteen suunnitellussa alaryhmäanalyysissä verrataan epiduraalihoidon tehokkuutta vasemman- ja oikeanpuolisella hemikolektomia potilailla.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Laparoskopic colorectal surgery, informed consent given.

Inkluusiokriteerit: kolonkirurgiset potilaat, joille on suunniteltu elektiivinen laparoskooppinenn oikeapuolinen hemikolektomia, ileokekaalinen resektio, vasemmanpuolinen hemikolektomia tai sigmasuolen resektio ja jotka ovat halukkaita osallistumaan tutkimukseen saatuaan siitä tietoa (informed concent).

E.4

Principal exclusion criteria

Severe renal, hepatic insufficiency, severe COPD, cancer T4, hematological disease, preoperative use of opioids, coagulation disturbances or any impossibility to put epidural catheter, over 50% risk of surgery conversion.

Ekskluusiokriteerit: vaikea munuaisten vajaatoiminta (GFR ≤ 30 ml/min), vaikea maksan vajaatoiminta (TT ≤ 50%), vaikea keuhkoahtaumatauti (FEV1 alle 30%), levinnyt syöpä (T4), hematologinen sairaus, preoperatiivinen opioidikäyttö, synnynnäinen tai muu hyytymishäiriö tai jokin muu este epiduraalikatetrin laittamiselle. Jos konversioriski (riski tähystysleikkauksen muuttumisesta avoleikkaukseksi) on arvioitu preoperatiivisesti olevan yli 50% tai muusta syystä hoitava anestesialääkäri katsoo epiduraalipuudutuksen olevan tärkeä potilaan kivun hoidossa, ei potilasta oteta tutkimukseen, jotta epiduraalikatetrin laittamisesta voidaan päättää ilman satunnaistamista. Potilaita, jotka eivät halua epiduraalikatetria, ei voida myöskään ottaa mukaan tutkimukseen.

E.5 End points

E.5.1

Primary end point(s)

Primary outcome is the opioid consumption 48h postoperatively.

Ensisijainen lopputulosmuuttuja on ryhmien välinen ero opioidin kulutuksessa 0- 48 tuntia leikkauksen jälkeen.

E.5.1.1

Timepoint(s) of evaluation of this end point

48h and 3 month after surgery.

48h leikkauksesta sekä 3kk leikkauksesta.

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

3 month

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Conventional pain treatment: paracetamol and regional anesthesia with 3.75-5% Ropivacain

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

Yes

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 2017-06-14.

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

160

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
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-08-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-22

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

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