Clinical Trials Register

Summary
EudraCT Number:	2013-001829-76
Sponsor's Protocol Code Number:	ProsMaMa13.1
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-08-08
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

Spain - AEMPS

A.2

EudraCT number

2013-001829-76

A.3

Full title of the trial

INTERCOSTAL BRANCHES BLOCK IN THE MIDAXILLARY LINE VERSUS PARAVERTEBRAL BLOCK, ULTRASOUND-GUIDED FOR NOT RECONSTRUCTIVE BREAST SURGERY. RANDOMIZED CLINICAL TRIAL

BLOQUEO DE LAS RAMAS DE LOS NERVIOS INTERCOSTALES EN LA LINEA MEDIO AXILAR VERSUS BLOQUEO PARAVERTEBRAL, GUIADOS POR ULTRASONIDOS PARA CIRUGÍA NO RECONSTRUCTIVA DE MAMA. ENSAYO CLÍNICO ALEATORIZADO

A.3.1

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

COMPARISON OF TWO ULTRASOUND-GUIDED TWO NERVE BLOCKS FOR NOT RECONSTRUCTIVE BREAST SURGERY. RANDOMIZED CLINICAL TRIAL

COMPARACIÓN DE DOS BLOQUEOS NERVIOSOS GUIADOS POR ULTRASONIDOS PARA CIRUGÍA DE MAMA NO RECONSTRUCTIVA. ENSAYO CLÍNICO ALEATORIZADO

A.4.1

Sponsor's protocol code number

ProsMaMa13.1

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	Paula Diéguez García
B.1.3.4	Country	Spain
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	Complejo Hospitalario Universitario A Coruña
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Paula Diéguez García
B.5.2	Functional name of contact point	Dra. Diéguez García
B.5.3	Address:
B.5.3.1	Street Address	As Xubias de Arriba 84, Servicio de Anestesia, 4ª planta
B.5.3.2	Town/ city	A Coruña
B.5.3.3	Post code	15006
B.5.3.4	Country	Spain
B.5.4	Telephone number	687995525
B.5.5	Fax number	981176380
B.5.6	E-mail	pauladieguez@yahoo.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	Chirocane 5 mg/ml solución inyectable/concentrado para solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	.... Avda. de Burgos, 91
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	LEVOBUPIVACAINA
D.3.2	Product code	N01B B10
D.3.4	Pharmaceutical form	Concentrate and solvent for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Perineural use
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

Sheduled patients for nor reconstructive unilateral breast surgery

Pacientes programados para cirugía no reconstructiva de mama unilateral

E.1.1.1

Medical condition in easily understood language

Sheduled patients for not reconstructive unilateral breast surgery and past informed consent without exclusion factos

Pacientes programadas para cirugía no reconstructiva de mama unilateral que hayan firmado consentimiento informado previamente sin factores de exclusión

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	PT
E.1.2	Classification code	10057654
E.1.2	Term	Breast cancer female
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 main objective of the clinical trial is the evaluation of the efficacy of the intercostal branches block in the midaxxilary line and paravertebral block in sheduled female patients for not reconstructive breast surgery.

El objetivo principal del ensayo clínico es la evaluación de la eficacia del bloqueo de las ramas de los nervios intercostales en la línea medio axilar versus bloqueo paravertebral en pacientes programadas para cirugía de mama no reconstructiva.

E.2.2

Secondary objectives of the trial

The secundary objectives are: security, difficulty in blockade, patient satisfaction.

Los objetivos secundarios son: la seguridad, la dificultad de los bloqueos y la satisfacción del paciente.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Sheduled female patients for not reconstructive unilateral breast surgery ( tumorectomy with oncoplasty or mastectomy, with or without sentinel node and/or linfadenectomy)
Clasification ASA I-III
Firmed informed consent before to the surgery
Aged 18 to 75 years old
Posibility for evaluation of pain through simple verbal scale and numerical scale
Pain down 3 for simple verbal scale in the inclusion moment

Pacientes programadas para cirugía no reconstructiva de mama unilateral (tumorectomía más oncoplastia o mastectomía, con o sin ganglio centinela y/o linfadenectomía)
Estado físico clasificación ASA I-III.
Firma del consentimiento informado previo a la cirugía.
Edad comprendida entre 18 y 75 años.
Capacidad para evaluar el dolor mediante una escala verbal simple y numérica.
Valoración del dolor en el momento de ser incluida en el estudio sea EVS inferior a 3

E.4

Principal exclusion criteria

Personal history of disorders of hemostasis and / or previous history of abnormal bleeding evidence
Local infection at the site of the puncture and / or to puncture prior systemic
Contraindications to study medication
Muscle or neurological disease, preexisting peripheral or central
Patients with prior history of opioid
Pregnancy or lactation (women of childbearing age will be a urine pregnancy test prior to surgery the same day of surgery)
Difficulties in assessing pain or inability to understand or assist in the development of the study (psychiatric illness, cognitive impairments).
Active Chronic alcoholism or drug addiction.
BMI <20 or> 30 kg/m2
Chronic treatment with NSAIDs, antidepressants, anticonvulsants or opioids.
Rejection of the patient.

Antecedentes personales de alteraciones de la hemostasia y/o historia previa de evidencia de sangrado anormal
Infección local en el lugar de la punción y/o sistémica previa a punción
Contraindicaciones para la medicación del estudio
Enfermedad muscular o neurológica, periférica o central preexistente
Pacientes con historia previa de consumo de opiáceos
Embarazo o periodo de lactancia (en mujeres en edad fértil se realizará un test de embarazo en orina previo a la cirugía el mismo día de la intervención)
Dificultades para evaluar el dolor o incapacidad para entender o colaborar en el desarrollo del estudio (enfermedades psiquiátricas, deterioros cognitivos).
Alcoholismo crónico o drogadicción activa.
Índice de masa corporal < de 20 ó > 30 Kg/m2
Tratamientos crónicos con AINES, antidepresivos, antiepilépticos u opioides.
Rechazo de la paciente.

E.5 End points

E.5.1

Primary end point(s)

a) Variables response
 efficacy variables
1. Postoperative pain (measured on arrival in the PACU, at 3h, 6h, 12h, 18h and 24h).
a. Verbal scale (VRS): no pain / mild / moderate pain / severe pain / pain unbearable.
b. Numerical visual scale (EVN): from 0-10, with 0 being no pain and 10 the worst pain imaginable. So be valued as: EVN 0 the no pain, EVN <3 mild pain, moderate pain 3-7 EVN EVN> 7 and severe pain.
Two. Rescue opioid requirements: at 24 hours will determine whether: not used any dose / dose was used / is used as much or more than 2 doses.
Three. Quality and quantity of sleep:
I. Sleep Quality: through verbal categorical scale: bad / average / good.
II. Amount of sleep: by recording the number of hours catalogándose as: <3h / 3-6h /> 6h.
 Safety Variables
1. Percentage of patients with nausea and / or vomiting postoperatively, both assessed as absence / presence of sensation of nausea / vomiting presence / or both.
Two. Lock Related (AL systemic toxicity, pneumothorax, paresthesia)
Three. Other: such as itching, dizziness, sedation, hypoventilation, etc..
 Secondary endpoints
1) blockade Difficulty: using the following ratings:
 block performance time recorded in minutes from the moment that starts at ultrasound examination until the blockade ends withdrawing all necessary material.
 existing adipose Panniculus measured in centimeters, by the criterion of depth in the ultrasound image (displayed consistently on the screen), and will be registered prior to puncture and / or injection.
 Complications during the block existing (hematoma, injury to adjacent structures, pleural puncture)
 Difficulty ultrasound visibility: using assessment scale: very easy / easy / medium / hard / very hard.
 Ease of sight of the needle during puncture: very easy / easy / medium / hard / very hard.
2) patient satisfaction with respect to the locking done by the scale: Very poor / Poor / Fair / Good / Very good.
b) General variables
- Demographic (Age, Weight (kg) Height (in cm))
- ASA physical status
- Type of surgery
- Side of surgery

a) Variables respuesta
 Variables de eficacia
1. Dolor postoperatorio (medido a la llegada a la URPA, a las 3h, 6h, 12h, 18h y 24 h).
a. Escala verbal simple (EVS): no dolor/ dolor leve/ dolor moderado/ dolor severo/ dolor insoportable.
b. Escala visual numérica (EVN): de 0 a 10, siendo 0 la ausencia de dolor y 10 el máximo dolor imaginable. Así será valorado como: EVN 0 el no dolor, EVN < 3 el dolor leve, EVN 3-7 el dolor moderado, EVN > 7 como dolor severo.
2. Necesidad de opiáceos de rescate: a las 24 horas se determinará si: no se empleó ninguna dosis/ se empleó una dosis/ se emplearon igual o más de 2 dosis.
3. Calidad y cantidad del sueño:
I. Calidad de sueño: mediante una escala categórica verbal: malo/ regular/ bueno.
II. Cantidad de sueño: mediante el registro del número de horas catalogándose como: <3h/ 3-6h/ >6h.
 Variables de seguridad
1. Porcentaje de pacientes que presentan náuseas y/o vómitos postoperatorios, evaluados como ausencia de ambas/ presencia de sensación nauseosa/ presencia de vómitos / o ambas cosas.
2. Relacionados con el bloqueo (toxicidad sistémica por AL, neumotórax, parestesias)
3. Otras: tales como prurito, mareo, sedación, hipoventilación, etc.
 Variables secundarias
1) Dificultad de realización del bloqueo: mediante las siguientes valoraciones:
 Tiempo de realización del bloqueo registrado en minutos desde el momento en que se inicia en examen por ultrasonidos hasta que se finaliza el bloqueo retirándose todo el material necesario para ello.
 Panículo adiposo existente medido en centímetros, mediante el criterio de profundidad en la imagen de ultrasonidos (se visualiza de manera constante en la pantalla), y será registrado previo a la punción y/o inyección.
 Complicaciones existentes durante el bloqueo (hematoma, lesión de estructuras adyacentes, punción pleural)
 Dificultad de visibilidad mediante ultrasonidos: mediante la escala de valoración: muy fácil/ fácil/ medio/ difícil/ muy difícil.
 Facilidad de visión de la aguja durante la punción: muy fácil/ fácil/ medio/ difícil/ muy difícil.
2) Satisfacción de la paciente con respecto al bloqueo realizado, mediante la escala: Muy mala/ Mala/ Regular/ Buena/ Muy buena.
b) Variables generales
- Características demográficas (Edad, Peso (en Kg), Talla (en cm))
- Estado físico ASA
- Tipo de cirugía
- Lado de la cirugía

E.5.1.1

Timepoint(s) of evaluation of this end point

In the postoperative room, at 3, 6, 12, 18 and 24 hours in postoperative time.

A la llegada a Reanimación, a las 3, 6, 12, 18 y 24 horas en el postoperatorio

E.5.2

Secondary end point(s)

a.Evaluar safety of both techniques.
b.Evaluar patients' satisfaction regarding the successful block.
c.Determinar the difficulty of blockade.
d.Registro of the demographic characteristics of the study population, type of surgery, physical and surgical side.

a.Evaluar la seguridad de ambas técnicas.
b.Evaluar la satisfacción de las pacientes con respecto al bloqueo realizado.
c.Determinar la dificultad de realización del bloqueo.
d.Registro de las características demográficas de la población a estudio, tipo de cirugía, estado físico y lado quirúrgico.

E.5.2.1

Timepoint(s) of evaluation of this end point

24 hours postoperative

24 horas en postoperatorio

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

Yes

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

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Mismo medicamento empleado en otra localización

The same medicinal product but in the other side

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

E.8.9.2

In all countries concerned by the trial months

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:

100

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

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

120

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)

No different from usual clinical practice

No es diferente de la práctica clínica habitual

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

2013-10-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-07-04

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

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