Clinical Trials Register

Summary
EudraCT Number:	2019-001016-35
Sponsor's Protocol Code Number:	ZUH-UMPR-MICB
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:	2019-03-14
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

2019-001016-35

A.3

Full title of the trial

The ultrasound-guided multiple-injection costotransverse block for mastectomy and primary reconstructive surgery. A double blind, randomised, placebo controlled trial.

A.3.1

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

Improving pain management for breast cancer surgery using an ultrasound-guided nerve block.

A.4.1

Sponsor's protocol code number

ZUH-UMPR-MICB

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	Associate Professor, Consultant Jens Børglum
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	Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde
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	Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde
B.5.2	Functional name of contact point	Jens Børglum
B.5.3	Address:
B.5.3.1	Street Address	Sygehusvej 10
B.5.3.2	Town/ city	Roskilde
B.5.3.3	Post code	DK4000
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+4530700120
B.5.6	E-mail	jens.borglum@gmail.com

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	Ropivacaine
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.3.1	Product name	Ropivacaine
D.3.4	Pharmaceutical form	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	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	Infiltration

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Postoperative pain following mastectomy and reconstructive surgery due to breast cancer.

E.1.1.1

Medical condition in easily understood language

Pain following breast cancer surgery (removal of the breast with reconstruction).

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	10026881
E.1.2	Term	Mastectomy radical
E.1.2	System Organ Class	100000004865

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	10051042
E.1.2	Term	Plastic surgery NOS
E.1.2	System Organ Class	100000004865

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	10006188
E.1.2	Term	Breast cancer female NOS
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

We wish to conduct a randomized, placebo controlled and double blind study, comparing the effect of the ultrasound-guided multiple-injection costotransverse block (MICB) vs. placebo. Our aim with this study is to investigate the efficacy of the MICB vs. placebo in patients undergoing unilateral mastectomy and primary reconstructive surgery due to breast cancer. Our hypothesis is, that the unilateral MICB will significantly reduce the opioid consumption during the first 24 postoperative hours and significantly reduce the Numerical Rating Scale pain score (0-10)
and opioid related side effects.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Scheduled for elective unilateral mastectomy and primary reconstructive surgery (UMPR) with subpectoral implant due to breast cancer

Age above/equal to 18 years at the date of inclusion

Have received thorough information, orally and in written, and signed the “Informed Consent” form on participation in the study.

E.4

Principal exclusion criteria

Scheduled for elective UMPR surgery due to breast cancer combined with simultaneous contralateral major breast surgery (mastectomy, mastopexy and subpectoral breast reconstruction). Minor contralateral surgery (e.g. lipofilling) are accepted.

Scheduled free flap reconstructive surgery

Inability to cooperate

Inability to speak, read and understand Danish

Allergy to local anaesthetics or opioids

Daily intake of opioids, according to the investigators decision

Illegal drug and/or substance abuse, according to the investigators decision

Local infection at the site of injection or systemic infection

Difficult sonoanatomical visualisation of the target area necessary for the block execution

Substantial co-morbidity, ASA>3

Severe hypovolemia

Pregnant or breastfeeding

E.5 End points

E.5.1

Primary end point(s)

The primary end point of this study is total morphine consumption in the first 24 postoperative hours.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 hours postoperative.

E.5.2

Secondary end point(s)

Pain intensity (NRS 0-10/10) in the study period at T0 (arrival in the PACU), after 15 minutes, 30 minutes, 45 minutes and one hour. And pain intensity (NRS 0-10/10) in the intervals
o [ arrival at the ward - 4 hrs. postop ]
o ] 4 hrs. postop – 8 hrs. postop ]
o ] 8 hrs. postop – 12 hrs. postop ]
o ] 12 hrs. postop – 16 hrs. postop ]
o ] 16 hrs. postop – 20 hrs. postop ]
o ] 20 hrs. postop – 24 hrs. postop ]

Morphine consumption at 4, 8, 12, 16 and 20 postoperative hours.

Duration of block (time to first opioid).

Patient satisfaction with application of the block.

The degree of morphine-related side effects (PONV, itching, fatigue, etc.).

Time from operation to ambulation (bed to chair to walking)

Time to discharge (days).

Quality of Recovery – 15 score (QoR15).

The incidence of chronic pain 1 year after surgery

E.5.2.1

Timepoint(s) of evaluation of this end point

The research period is 14 days postoperative with interrim timepoints regarding block performance and acute postoperative pain.
Chronic pain follow-up at 1 year.

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

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

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 + 14 days.

LVLS + 1 year regarding chronic pain follow-up.

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

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 2019-03-14.

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

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

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-03-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-05-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-12-08

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