Clinical Trials Register

Summary
EudraCT Number:	2017-001430-25
Sponsor's Protocol Code Number:	FPS-CES-2017-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-06-22
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

Spain - AEMPS

A.2

EudraCT number

2017-001430-25

A.3

Full title of the trial

The effects of sufentanil or morphine added to hyperbaric bupivacaine in
spinal anaesthesia for elective caesarean section.

EFECTOS DEL SUFENTANILO O LA MORFINA JUNTO CON BUPIVACAINA
HIPERBARICA EN ANESTESIA ESPINAL PARA CESAREA ELECTIVA.

A.3.1

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

The effects of several local anesthetics in spinal anaesthesia for elective caesarean section.

EFECTOS VARIOS ANESTÉSICOS LOCALES EN ANESTESIA ESPINAL PARA CESAREA ELECTIVA.

A.4.1

Sponsor's protocol code number

FPS-CES-2017-01

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	Fundación Pública Andaluza Progreso y Salud
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	Fundación Pública Andaluza Progreso y Salud
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	Fundación Pública Andaluza Progreso y Salud
B.5.2	Functional name of contact point	Marta Reboredo Ares
B.5.3	Address:
B.5.3.1	Street Address	Avda. Américo Vespucio, nº 15, Edif S-2
B.5.3.2	Town/ city	Sevilla
B.5.3.3	Post code	41092
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034955040450
B.5.5	Fax number	0034955040457
B.5.6	E-mail	gestionensayosclinicos.fps@juntadeandalucia.es

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	SUFENTANIL G.E.S. 5 MG/ML
D.2.1.1.2	Name of the Marketing Authorisation holder	G.E.S. GENÉRICOS ESPAÑOLES LABORATORIO, S.A.
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.3.4	Pharmaceutical form	Solution for injection
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	SUFENTANIL
D.3.9.1	CAS number	56030-54-7
D.3.9.4	EV Substance Code	SUB10671MIG
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	MORPHINE B.BRAUN10 10 MG/ML
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun Medical, S.A.
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.3.4	Pharmaceutical form
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	MORPHINE
D.3.9.1	CAS number	57-27-2
D.3.9.3	Other descriptive name	MORPHINE
D.3.9.4	EV Substance Code	SUB03332MIG
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	10
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: 3
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	INIBSACAIN HIPERBARICA 0,5 % SOLUCION INYECTABLE
D.2.1.1.2	Name of the Marketing Authorisation holder	Inibsa Hospital, SLU
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.3.4	Pharmaceutical form
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	BUPIVACAINE
D.3.9.1	CAS number	2180-92-9
D.3.9.4	EV Substance Code	SUB05983MIG
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.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

CESAREAN

CESAREA

E.1.1.1

Medical condition in easily understood language

CESAREAN

CESAREA

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

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

Evaluation of the postoperative pain in caesarean section with
hyperbaric bupivacaine 0.5% added to sufentanil (5mcg) or morphine
(0.1mg).

Evaluar en anestesia espinal para cesárea electiva qué asociación de
bupivacaína hiperbárica 0,5% más opioide: sufentanilo (5 mcg) o
morfina (0,1mg) presenta un control del dolor más óptimo.

E.2.2

Secondary objectives of the trial

1. Better analgesic quality for the mother during the surgery period.
2. Leads to a lower consumption of intravenous morphine within 24 hours after surgery.
3.leads to levels of verbal pain scales less than 3, 6, 12 and 24 hours after surgery.
4. Better satisfaction for the pain control during the 24 hours after the surgery.
5. Allows the patients a start of sedestation and earlier bipedestation.
6. Impacts in a shorter hospitalization time.
7. Causes less side effects for the mother regarding hemodynamic alterations during the surgery period, nausea, vomiting, pruritus, tremor, Urinary retention, sedation, respiratory depression, headaches, motor, sensory or autonomic deficits.
8. Evaluate in spinal anesthesia for elective cesarean what association of bupivacaine plus opioid: sufentanil or morphine found lower values in the Apgar test: at the first minute and at 5 minutes; and in the pH collected from an umbilical cord gasometry analysis.

1. Mejor calidad analgésica para la madre durante el intraoperatorio.
2. Evaluar en anestesia espinal en las 24 horas posteriores de la cirugía.
3. Evaluar en anestesia espinal para cesárea electiva qué asociación de bupivacaína hiperbárica más opioide: sufentanilo o morfina, conduce a niveles de escalas verbales de dolor menores a las 3, 6, 12 y 24 horas posteriores de la cirugía.
4. Control del dolor durante las 24 horas posteriores a la cirugía.
5. Medición del comienzo de sedestación y bipedestación más precoz.
6. Tiempo de ingreso hospitalario más corto.
7. Efectos secundartios para la madren
8. Evaluar en anestesia espinal para cesárea electiva qué asociación de bupivacaína más opioide: sufentanilo o morfina encuentra valores más bajos en el test de Apgar al minuto y a los 5 minutos; y en el pH recogido de una gasometría sanguínea venosa del cordón umbilical.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Pregnant with 18 years old or more
- Pregnant with 36 gestational weeks or more
- Elective caesarean
- ASA I-II
- Informed consent signed

a) Pacientes de al menos 18 años.
b) Pacientes de al menos 36 semanas de gestación.
c) Pacientes programadas para cesárea no urgente.
d) Pacientes catalogadas en el estado físico de la “American Society Anesthesiologists” (ASA) como grado I-II, y sin condiciones patológicas fetales importantes.
e) Firma del consentimiento informado que les permita formar parte del estudio.

E.4

Principal exclusion criteria

- Pregnant don't accept the spinal technique
- Spinal technique contraindicated
- ASA>II
- multiple pregnant
- 3 or more caesarean section previously
- BMI > 40
- Language barrier
- Patients with pre-eclampsy
- Patients with chronic pain
- Patients with psychiatric disease or drugs addiction
- Patient with allergy to any drugs used

a) Gestantes que rechacen la técnica espinal.
b) Pacientes con contraindicación para anestesia espinal.
c) Pacientes con clasificación ASA>II.
d) Pacientes con embarazo múltiple.
e) Pacientes con tres o más cesáreas previas,
f) Pacientes con IMC mayor o igual a 40 kg/m2.
g) Barrera lingüística.
h) Pacientes que presenten pre-eclampsia.
i) Pacientes con historia de dolor crónico.
j) Pacientes con historia de enfermedades psiquiátricas o de abuso de drogas.
k) Pacientes con alergia a alguno de los fármacos empleados en el estudio.

E.5 End points

E.5.1

Primary end point(s)

Timing since the spinal punction to the first morphine bolus demanded.

Tiempo desde la punción espinal hasta el primer bolo de analgesia con
morfina.

E.5.1.1

Timepoint(s) of evaluation of this end point

It depends on the drug administred

Depende del fármaco administrado

E.5.2

Secondary end point(s)

Morphine consumption within 24 hours.

Consumo de morfina en 24 horas

E.5.2.1

Timepoint(s) of evaluation of this end point

24 hours

24 horas

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

E.6.4

Safety

Yes

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

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)

Yes

E.8.2.2

Placebo

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

Patient Discharge

Alta del paciente

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:

F.1.3

Elderly (>=65 years)

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

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

Yes

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)

Usual Clinical Practice

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

2017-11-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-10-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-07-28

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