Clinical Trials Register

Summary
EudraCT Number:	2017-003113-26
Sponsor's Protocol Code Number:	CoLeBu
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:	2018-04-09
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

2017-003113-26

A.3

Full title of the trial

Hemodynamic safety of isobaric levobupivacaine versus isobaric bupivacaine for spinal anesthesia in patients over 65 years, underwent hip surgery.

Seguridad hemodinámica de la levobupivacaína isobárica frente a la bupivacaína isobárica para anestesia subaracnoidea en pacientes de más de 65 años, intervenidos de fractura de cadera.

A.3.1

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

Hemodynamic safety of isobaric levobupivacaine versus isobaric bupivacaine for spinal anesthesia in patients over 65 years, underwent hip surgery.

Seguridad hemodinámica de la levobupivacaína isobárica frente a la bupivacaína isobárica para anestesia subaracnoidea en pacientes de más de 65 años, intervenidos de fractura de cadera.

A.4.1

Sponsor's protocol code number

CoLeBu

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	ROSA HERRERA CASTRO
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	ROSA HERRERA CASTRO
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	ROSA HERRERA CASTROS
B.5.2	Functional name of contact point	ROSA HERRERA
B.5.3	Address:
B.5.3.1	Street Address	AVD. BLASCO IBÁÑEZ 17
B.5.3.2	Town/ city	VALENCIA
B.5.3.3	Post code	46010
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034961973847
B.5.6	E-mail	35606rhc@gmail.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	Levobupivacaine Kabi 5 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi España S.A.U
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	levobupivacaine 0.5%
D.3.2	Product code	levobupivacaine 0.5%
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	Intradural use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOBUPIVACAINE HYDROCHLORIDE
D.3.9.1	CAS number	27262-48-2
D.3.9.3	Other descriptive name	LEVOBUPIVACAINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB02904MIG
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	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	Inibsacaín 0.5% Inibsa
D.2.1.1.2	Name of the Marketing Authorisation holder	INIBSA HOSPITAL, S.L.U
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	Bupivacaine 0,5%
D.3.2	Product code	Bupivacaine 0,5%
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	Intradural use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BUPIVACAINE HYDROCHLORIDE
D.3.9.3	Other descriptive name	BUPIVACAINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB00902MIG
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

In patients 65 years or older undergoing hip surgery.

En pacientes de 65 años o más sometidos a cirugía de cadera.

E.1.1.1

Medical condition in easily understood language

In patients 65 years or older undergoing hip surgery

En pacientes de 65 años o más sometidos a cirugía de cadera.

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	PT
E.1.2	Classification code	10051060
E.1.2	Term	Hip surgery
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Compare the hemodynamic effects from the systolic blood pressure values ??invasive (PASI) and invasive diastolic blood pressure (PADI), arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg , arterial oxygen saturation (SatO2) misobaric easured in%, pH (pH), blood hemoglobin (Hb) measured in g / dL, heart rate (HR / bpm) measured in beats per minute, oxygen saturation (SpO2 %) measured in% and hourly diuresis (D / h) measured in ml / h of isobaric levobupivacaine and isobaric bupivacaine both with fentanyl in combination, in patients 65 years or older undergoing hip surgery.

Comparar los efectos hemodinámicos a partir de los valores de presión arterial sistólica invasiva (PASI) y de presión arterial diastólica invasiva (PADI), presión parcial arterial de oxígeno (PaO2) y presión parcial arterial de dióxido de carbono (PaCO2), medidas en mmHg, saturación arterial de oxígeno (SatO2) medida en %, pH (pH), de hemoglobina arterial (Hb) medida en g/dl, de frecuencia cardíaca (Fc/lpm) medida en latidos por minuto, de saturación parcial de oxigeno (SpO2%) medida en % y de diuresis horaria (D/h) medida en ml/h de la levobupivacaína isobárica y de la bupivacaína isobarica ambas en combinación con fentanilo, en pacientes de 65 años o más sometidos a cirugía de cadera

E.2.2

Secondary objectives of the trial

Assess potential adverse events during surgery and 48 hours of surgery. Adverse events include adverse cardiovascular and respiratory rate from the use of levobupivacaine and bupivacaine isobariric , events related to both surgical and anesthetic techniques and exitus .

Valorar los posibles eventos adversos durante la cirugía y a las 48 horas del acto quirúrgico. Los eventos adversos incluirían efectos adversos de tipo cardiovascular y respiratorio derivados del uso de la levobupivacaína isobárica y de la bupivacaína isobárica a, eventos relacionados con las técnicas tanto quirúrgica como anestésica y el exitus.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

men and women 65 years or older, who meet the requirements in the pre-anesthetic to be treated with spinal anesthesia with levobupivacaine and bupivacaine and fentanyl or fentanyl, fitness: from I to IV, according to the American Society of Anesthesiologists (ASA), weight> 40 kg, height> 140 cm, body mass index (BMI) <50 kg/m2, pathology
cardiovascular, respiratory, renal and endocrine-metabolic to give their informed consent for participation in the study.

hombres y mujeres de 65 años o más edad, que cumplan los requisitos en la visita pre-anestésica para ser tratados con anestesia intradural con levobupivacaína y fentanilo o bupivacaína y fentanilo, estado físico: entre I y IV, según la Asociación Americana de Anestesiología (ASA), peso > 40 kg, altura >140 cm, índice de masa corporal (IMC) <50 kg/m2, patología
cardiovascular, respiratoria, renal y endocrino-metabólica que den su consentimiento informado para su participación en el estudio.

E.4

Principal exclusion criteria

Patients with uncontrolled hypertension (systolic blood pressure values ??noninvasive> 180 mmHg and / or diastolic blood pressure noninvasively> 110mmHg), HR> 120 bpm, SpO2 <90% on arrival in the operating room and with contraindications to the realization neuraxial anesthesia (patient refusal, infection at the site of puncture or lancing different, neuromuscular degenerative disease, hypovolemia, coagulopathy or anticoagulant therapy, and morbid obesity extreme increase in intracranial pressure).

Pacientes con hipertensión arterial no controlada (valores de presión arterial sistólica no invasiva>180 mmHg y/o de presión arterial diastólica no invasiva>110mmHg), Fc>120 lpm, SpO2<90% a la llegada a quirófano y con contraindicación a la realización de anestesia neuroaxial (rechazo del paciente, infección en el sitio de punción o distinto al de punción, enfermedad neuromuscular de tipo degenerativo, hipovolemia, coagulopatía o tratamiento anticoagulante, obesidad mórbida extrema y aumento de la presión intracraneal).

E.5 End points

E.5.1

Primary end point(s)

hemodynamic variables

invasive systolic blood pressure (PASI) measured in mmHg
invasive diastolic blood pressure (PADI), measured in mmHg
heart rate (Fc / lpm), measured in beats per minute
partial oxygen saturation (SpO2%) measured in%
hourly diuresis (D / h), measured in ml / h

Variables hemodinámicas

presión arterial sistólica invasiva (PASI), medida en mmHg
presión arterial diastólica invasiva (PADI), medida en mmHg
de frecuencia cardíaca (Fc/lpm), medida en latidos por minuto
de saturación parcial de oxigeno (SpO2%) medida en %
diuresis horaria (D/h), medida en ml/h

E.5.1.1

Timepoint(s) of evaluation of this end point

entry into the operating room, 30 minutes to the end of anesthesia

entrada en quirófano, 30 minutos y final de la anestesia

E.5.2

Secondary end point(s)

A. Intraoperative adverse events:
1) Cardiovascular and Respiratory: Venous air embolism (VAE), deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex)
2) Other: Acute renal failure (ARF), vomiting (V)
3) Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), nerve damage (ln), femur fracture (Fx f)
4) Associated with the anesthetic technique: paresthesia (pair), hematic puncture (ph), other

B.Postoperative adverse events (at 48 hours)
1) Cardiovascular and Respiratory: Deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex)
2) Other: Acute renal failure (ARF), UTI (Infu), vomiting (V).
3) Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), neurologic deficit (defnq), surgical wound infection (Infhq).
4) Associated with the anesthetic technique: neurological deficit (defn), postdural puncture headache (PDPH), back pain (Lumb).

A. Eventos adversos intraoperatorios:
1)Cardiovasculares y Respiratorios: embolia gaseosa venosa (EGV), Trombosis venosa profunda (TVP), Infarto agudo de miocardio (IAM), Accidente cerebrovascular (ACV), Insuficiencia cardíaca congestiva (ICC), Neumonía (N), Exitus (Ex)
2)Otros: Insuficiencia renal aguda (IRA), Vómitos (V)
3)Asociado a la técnica quirúrgica: Transfusión hematíes (Th), Transfusión plasma (Tpl), Lesión nerviosa (ln), Fractura de fémur (Fx f)
4)Asociado a la técnica anestésica: parestesias (par), punción hemática (ph), otros

B.Eventos adversos posoperatorios (a las 48 horas)
1)Cardiovasculares y Respiratorios: Trombosis venosa profunda (TVP), Infarto agudo de miocardio (IAM), Accidente cerebrovascular (ACV), Insuficiencia cardíaca congestiva (ICC), Neumonía (N), Exitus (Ex)
2)Otros: Insuficiencia renal aguda (IRA), Infección urinaria (Infu), Vómitos(V).
3)Asociado a la técnica quirúrgica: Transfusión hematíes (Th), Transfusión plasma (Tpl), Déficit neurológico (defnq), Infección de la herida quirúrgica (Infhq).
4)Asociado a la técnica anestésica: déficit neurológico (defn), cefalea pospunción dural (CPPD), lumbalgia (lumb).

E.5.2.1

Timepoint(s) of evaluation of this end point

48 hours from surgery

48 horas desde la cirugía

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

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

Last visit last patient

Última visita del último 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

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

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

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

Yes

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

150

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)

Treatment plans or care after the subject has completed participation in the study will be the control after 48 hours of possible adverse events associated with the anesthetic technique.

Los planes de tratamiento o cuidados después que el sujeto haya terminado la participación en el estudio será el control a las 48 horas de posibles eventos adversos asociados a la técnica anestésica

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

2018-05-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-04-26

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

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