Clinical Trials Register

Summary
EudraCT Number:	2021-003703-18
Sponsor's Protocol Code Number:	2021/04
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-07-13
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

France - ANSM

A.2

EudraCT number

2021-003703-18

A.3

Full title of the trial

Opioid free anesthesia in total hip arthroplasty. A randomized, controlled and triple-blind clinical trial.

Anesthésie sans opioïdes dans la chirurgie prothétique de hanche en ambulatoire. Etude randomisée, contrôlée, en triple aveugle.

A.3.1

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

The benefit of opioid free anesthesia on postoperative pain in patient undergoing hip surgery.

Intérêt de l'anesthésie sans opioïdes sur la douleur postopératoire des patients opérés d'une prothèse de hanche.

A.3.2

Name or abbreviated title of the trial where available

OFATHA

A.4.1

Sponsor's protocol code number

2021/04

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	CMC Ambroise Paré
B.1.3.4	Country	France
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	CMC Ambroise Paré
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CMC Ambroise Paré
B.5.2	Functional name of contact point	Service Recherche Clinique
B.5.3	Address:
B.5.3.1	Street Address	25-27 Boulevard Victor Hugo
B.5.3.2	Town/ city	Neuilly-sur-Seine
B.5.3.3	Post code	92200
B.5.3.4	Country	France
B.5.4	Telephone number	+33146415079
B.5.5	Fax number	+33146415086
B.5.6	E-mail	recherche@clinique-a-pare.fr

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	Dexmedetomidine 100 µg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Mylan S.A.S., France
D.2.1.2	Country which granted the Marketing Authorisation	France
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 infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXMEDETOMIDINE HYDROCHLORIDE
D.3.9.1	CAS number	145108-58-3
D.3.9.4	EV Substance Code	SUB20317
D.3.10	Strength
D.3.10.1	Concentration unit	µg/kg microgram(s)/kilogram
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1.4
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	Sufentanil 5 µg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Mylan S.A.S., France
D.2.1.2	Country which granted the Marketing Authorisation	France
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SUFENTANIL CITRATE
D.3.9.1	CAS number	60561-17-3
D.3.9.4	EV Substance Code	SUB04616MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	15
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

Total hip arthroplasty

Prothèse de hanche

E.1.1.1

Medical condition in easily understood language

Hip surgery

Chirurgie de la hanche

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	SOC
E.1.2	Classification code	10042613
E.1.2	Term	Surgical and medical procedures
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLGT
E.1.2	Classification code	10043413
E.1.2	Term	Therapeutic procedures and supportive care NEC
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10002185
E.1.2	Term	Analgesia supportive care
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10036276
E.1.2	Term	Postoperative analgesia
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

Evaluate the benefit of OFA strategy with dexmedetomidine infusion in postoperative analgesia defined by the oxycodone consumption in the first 24 hours after outpatient total hip arthroplasty.

Evaluer l’intérêt de la stratégie OFA avec administration de dexmédétomidine sur l’analgésie post opératoire définie par la consommation d’oxycodone pendant les 24 premières heures des patients opérés d’une prothèse totale de hanche (PTH) en ambulatoire.

E.2.2

Secondary objectives of the trial

1.Evaluate the analgesia in post-anesthesia care unit (PACU).
2.Evaluate the postoperative pain at rest during the first 24 hours post surgery.
3.Evaluate the postoperative pain at walk.
4.Evaluate side effects associated with opioids and dexmedetomidine.
5.Evaluate the outpatient care failure.
6.Evaluate the length of stay in post-anesthesia care unit (PACU).
7.Evaluate the time to recover the ability to walk.

1.Evaluer l’analgésie en salle de surveillance post-interventionnelle (SSPI).
2.Evaluer le niveau de douleur ressenti par le patient au repos dans les 24 heures post opératoires.
3.Evaluer le niveau de douleur ressenti par le patient à la marche.
4.Evaluer les effets secondaires associés à la prise d’opiacés et à la prise de dexmédétomidine.
5.Evaluer l’échec de prise en charge ambulatoire.
6. Evaluer la durée de séjour en SSPI.
7.Evaluer le délai de reprise de la marche.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-18 years and older
-Undergoing outpatient primary total hip arthroplasty under general anesthesia with laryngeal mask
-Consent for participation
-Affiliation to the social security system

-Âgés de plus de 18 ans,
-Programmé pour une PTH de première intention en ambulatoire sous anesthésie générale avec masque laryngé,
-Ayant donné leurs consentements de participation conformément à la réglementation,
-Bénéficiant d'un régime de sécurité sociale.

E.4

Principal exclusion criteria

-Heart rate < 60 bpm
-Chronic pain syndrome requiring preoperative morphine use (class 3)
-Contraindication for : paracetamol, ketoprofen, nefopam, oxycodone, propofol, ketamine, cisatracurium, sufentanyl, ropivacaine.
-Contraindication for dexmedetomidine : hypersensitivity to the active substance or to any of the excipients, advanced cardiac block (grade 2 or 3) unless paced ; uncontrolled hypotension ; acute cerebrovascular conditions
-Contraindication to laryngeal mask : old insulin-dependent diabetes, gastro-oesophageal reflux, morbid obesity (defined by BMI > 35)
-Pregnant or breastfeeding women
-Women of child bearing potential without contraception (any contraceptive method used regularly and appropriately with a low failure rate: <1% per year),
-A mental or linguistic inability to understand the study,
-Patient under protection of the adults (guardianship, curators or safeguard of justice),
-Patient included or planning to be included in another clinical trial relating to medications

-Fréquence cardiaque inférieure à 60 bpm au moment de l’inclusion,
-Douloureux chronique défini par la prise d’antalgique de palier 3 en préopératoire,
-Contre-indication à l’un des médicaments suivant : paracétamol, kétoprofène, néfopam, oxycodone, propofol, kétamine, cisatracurium, sufentanil, ropivacaine,
-Contre-indications à la dexmédétomidine : hypersensibilité à la substance active ou à l’un des excipients ; bloc cardiaque avancé (niveau 2 ou 3) sauf si pacemaker ; hypotension non-contrôlée ; pathologie cérébrovasculaire aiguë,
-Contre-indication au masque laryngé : diabète insulino-dépendant ancien, reflux gastro-oesophagien symptomatique, obésité morbide (définie par un IMC> 35),
-Femmes enceintes ou allaitantes,
-Femmes en âge de procréer et n’utilisant pas une méthode de contraception efficace (tout moyen de contraception utilisé de manière régulière et appropriée dont le taux d’échec est faible : <1% par an),
-Incapacité de compréhension,
-Patient sous tutelle, sous curatelle ou sous sauvegarde de justice,
-Patient inclus ou sur le point d’être inclus dans un autre protocole de recherche relatif aux médicaments.

E.5 End points

E.5.1

Primary end point(s)

Postoperative cumulated dose of oxycodone in oral morphine equivalent (OME, mg)

Quantité totale cumulée d'oxycodone en postopératoire en oral morphine équivalent (OME, mg)

E.5.1.1

Timepoint(s) of evaluation of this end point

From the arrival time in PACU to 24h after surgery.

A partir de l'heure d'arrivée en SSPI jusqu'à 24h après l'intervention.

E.5.2

Secondary end point(s)

1.Total amount of oxycodone (mg) administered in PACU.
2. Postoperative pain at rest (numeric rating scale ranging from 0 to 10: 0= no pain; 10= worst imaginable pain).
3. Postoperative pain at mobilization (numeric rating scale ranging from 0 to 10: 0= no pain; 10= worst imaginable pain).
4. Complications due to:
-oxycodone: postoperative nausea and vomiting, drowsiness, acute urinary retention, pruritus, disorientation.
-dexmedetomidine: bradycardia defined by HR<50 bpm or requiring the use of atropine; Hypotension defined by SBP<90 mmHg or requiring the use of vasoconstrictors (phenylephrine or ephedrine); hypertension defined by SBP>160 mmHg.
5. Unplanned hospitalizations (failure of outpatient care).
6. Length of PACU stay (min).
7. Time for recovery the ability to walk (min).

1.Quantité d’oxycodone (mg) administrée en SSPI.
2. Douleur postopératoire au repos (échelle numérique cotée de 0 à 10: 0 = aucune douleur ; 10 = douleur maximale imaginable).
3. Douleur postopératoire à la marche (échelle numérique cotée de 0 à 10: 0 = aucune douleur ; 10 = douleur maximale imaginable).
4. Recueil d'éventuelles complications dues à:
- l'oxycodone: nausées et vomissements post opératoires (NVPO), somnolence, rétention aiguë d’urine, prurit, désorientation.
-la dexmedetomidine: bradycardie définie par une FC < 50 bpm ou nécessitant l’utilisation d’atropine; hypotension définie par une PAS < 90 mmHg ou nécessitant l’utilisation de vasoconstricteurs (phényléphrine ou éphédrine); hypertension définie par une PAS > 160 mmHg.
5.Hospitalisations non prévues (échec de prise en charge ambulatoire).
6. Durée de séjour en SSPI (min)
7. Délai de reprise de la marche (min)

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Postoperative period: PACU stay.
2. Postoperative period: 24h after surgery
3. Days 0 and 1
4. From the first dexmedetomidine infusion to 48h after surgery.
5. Postoperative period: 24h after surgery
6. Postoperative period: from the arrival in PACU to the PACU discharge.
7. Postoperative period: from the arrival in PACU to the first successful walk test.

1. Période postopératoire: séjour en SSPI.
2. Période postopératoire: du retour du bloc jusqu'à 24h.
3. Jours 0 et 1
4. A partir de la première injection de dexmédétomidine jusqu'à 24h après l'intervention.
5.Période postopératoire: du retour du bloc jusqu'à 24h.
6. Période postopératoire: de l'arrivée en SSPI jusqu'à la sortie de la SSPI.
7. Période postopératoire: de l'arrivée en SSPI jusqu'au premier test de marche réussi.

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

Yes

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)

Yes

E.7.4

Therapeutic use (Phase IV)

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

LVLS

Dernière visite de la dernière personne participant à l'essai.

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

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

AUCUN

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

2021-08-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-02-02

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