Clinical Trials Register

Summary
EudraCT Number:	2012-000989-37
Sponsor's Protocol Code Number:	002-2012M
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-12
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

Netherlands - Competent Authority

A.2

EudraCT number

2012-000989-37

A.3

Full title of the trial

Local Infiltration Anaesthesia in Total Hip Arthroplasty by Anterior Supine Intermuscular Approach

Locale infiltratie anesthesie in totale heup arthroplastie met de anterior supine intermusculaire benadering

A.3.1

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

Extra local pain relief in total hip replacement

Extra plaatslijke verdoving met pijnmedicatie bij een totale heup vervanging

A.3.2

Name or abbreviated title of the trial where available

LIA in total hip arthroplasty

LIA bij totale heup arthroplastie

A.4.1

Sponsor's protocol code number

002-2012M

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	Reinier de Graaf Groep
B.1.3.4	Country	Netherlands
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	Reinier de Graaf Groep
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Reinier de Graaf Groep
B.5.2	Functional name of contact point	Department of orthopaedics
B.5.3	Address:
B.5.3.1	Street Address	Reinier de Graafweg 3-11
B.5.3.2	Town/ city	Delft
B.5.3.3	Post code	2625AD
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	0031152603718
B.5.5	Fax number	0031152604031
B.5.6	E-mail	N.Mathijssen@rdgg.nl

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	Ropivacaine HCl Fresenius Kabi
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi Nederland BV
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Ropivacaine
D.3.2	Product code	N01BB09
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	Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ropivacain HCl
D.3.9.1	CAS number	98717-15-8
D.3.9.2	Current sponsor code	N01BB09
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	2mg/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
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.3.11 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	Infiltration

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Local infiltration analgesia a multimodal pain management strategy in total hip arthroplasty. The Anterior Supine Intermuscular technique for THA procedures will allow the patient to mobilize much earlier postoperatively, however it has been hypothesized that it will give more pain direct postoperative. This study will investigate the effect of LIA in combination with the ASI technique.

E.1.1.1

Medical condition in easily understood language

Patients with a hip replacement surgery will have pain after the surgery. Due to this pain early mobilization is not possible. Local infiltration might reduce the pain after the operation.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

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

Determining the outcome of reversed and antegrade LIA in THA with ASI by analysing postoperative pain with the 100 mm Visual Analogue Scale (VAS), length of hospital stay, the amount of postoperative consumption of opioid pain medication as well as the consumption of other pain medication

E.2.2

Secondary objectives of the trial

not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patients aged 18 years and older.
• Patients willing to participate.
• ASA I and II.

E.4

Principal exclusion criteria

• Patients unwilling to participate.
• Mentally retarded.
• Neurological conditions potentially influence pain perception.
• Psychiatric conditions potentially influence pain perception.
• ASA III, IV and V.
• Cardiovascular impairment in the past.
• Abuse of alcohol or drugs.
• Known allergy for any element of the medication that is given.
• Medical contra indication for spinal anaesthesia.
• BMI > 40.
• Rheumatoid arthritis.

E.5 End points

E.5.1

Primary end point(s)

- Pain score (VAS) at day 1 at multiple moments: 1, 4 and 8 hours after operation in rest, and while and direct after mobilization starting at 4-6 hours after operation. At day 2 until the day of discharge at two moments.
- Cumulative consumption of opioid medication and pain medication.
- Length of Hospital Stay by amount of nights and number of hours between operation and discharge.

E.5.1.1

Timepoint(s) of evaluation of this end point

- VAS: 1,4,8 hours after operation in rest and direct after mobilization at 4-6 hours after operation. At day 2 until discharge at 2 standardized moments: morning and afternoon.

E.5.2

Secondary end point(s)

not applicable

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

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

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

After the last patient has been discharged from the hospital.
If there are signals of unexpected, serieus side effects, an interim analysis will be made and if necessary, the study will be ended.

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

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)

Referral to the general practionar if necessary

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

2012-03-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-01

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

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