Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
70
Countries
1
Sites
1
Anesthesia /Intensive care
Evaluate the impact of serratus block compared to local anesthesia, on the management of acute pain during the performance of pleural drainage in multipurpose intensive care unit.
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2024-07-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515722-83-00
- EudraCT number
- 2018-001621-47
- ClinicalTrials.gov
- NCT03984656
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
Evaluate the impact of serratus block compared to local anesthesia, on the management of acute pain during the performance of pleural drainage in multipurpose intensive care unit.
Secondary objectives 6
- Clinical tolerance of drainage.
- The intensity of pain at rest and during exercise after drainage.
- Lung capacity during forced inspiration measured by the Voldyne.
- Consumption of analgesics.
- Respiratory complications.
- Early rehabilitation.
Conditions and MedDRA coding
Anesthesia /Intensive care
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Etude pilote, prospective, contrôlée, randomisée, comparative, en simple aveugle Les patients seront randomisés en deux groupes parallèles en ouvert. La randomisation sera effectuée à l’aide du logiciel Clinsight®, mis en place par le data manager du CHU d’Amiens. Il s’agira d’une randomisation par minimisation avec stratification sur :
- L’évaluation de la douleur par échelle numérique (EN) réalisée avant l’intervention. (EN comprise entre 1-3, 4-6 et 7-10)
- Le service de prise en charge du patient
Les investigateurs, après s’être identifiés, se connecteront au site de randomisation de l’étude le jour de
l’inclusion et vérifieront les critères d’inclusion et de non inclusion. Si aucune incohérence n’est relevée,
le résultat de la randomisation s’affichera sous la forme : « Anesthésique locale » ou « Bloc Serratus ».
|
Randomised Controlled | Single | [{"id":70317,"code":1,"name":"Subject"}] | Groupe AL : Anesthésie locale: infiltration locale par 10 mL de Lidocaïne 20 mg/mL non adrénalinée Groupe S : Bloc Serratus: Injection sous échoguidage de 30 mL Ropivacaine 4,75 mg/mL |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patient aged 18 or over, not intubated, spontaneously ventilating.
- Free and informed consent signed.
- Affiliate to a social security scheme.
- Hospitalized in multipurpose intensive care unit including surgical resuscitation, cardiothoracic and respiratory resuscitation or continuing cardiothoracic and respiratory care services.
- Requiring gas or fluid pleural drainage.
Exclusion criteria 5
- Patient didn't agree to participate in the trial.
- Patient under guardianship or curatorship or deprived of liberty.
- Pregnant, parturient or breastfeeding woman.
- Allergy and contraindication to Lidocaine or Ropivacaine.
- Coagulation disorders.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Intensity of acute pain during pleural drainage (H0) by numerical scale (EN).
Secondary endpoints 10
- Intensity of acute pain by EN at rest and during exercise (forced inspiration) at the end of pleural drainage (H0).
- Intensity of acute pain from EN at rest and during exercise (cough and forced inspiration) after drainage over the first 24 hours (H0, H1, H6, H24).
- Clinical tolerance at the end of drainage (H0): MAP HR, FR, SpO2.
- Lung capacity in milliliters measured by the Voldyne (maximum inspired volume) H1, H6, H24.
- Respiratory complications: - atelectasis = auscultation + radiography or ultrasound - nosocomial pneumonia = 3 clinicoradiological criteria compatible with radiological infiltrate + hyperthermia (>38 or <36°C) or leukocytes (>12000 or <4000 GB/mm3) + purulent aspirations or suggestive auscultation or hypoxemia.
- Use of tracheal intubation.
- Early rehabilitation: time to first getting up, physiotherapy.
- Duration of drainage.
- Duration of stay in intensive care.
- Duration of installation of anesthesia.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB10382MIG · Substance
- Active substance
- Ropivacaine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 225 mg milligram(s)
- Max total dose
- 225 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10382MIG · Substance
- Active substance
- Ropivacaine
- Pharmaceutical form
- INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 225 mg milligram(s)
- Max total dose
- 225 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SUB88133 · Substance
- Active substance
- Lidocaine Hydrochloride
- Pharmaceutical form
- INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
Dexamethasone Sodium Phosphate
SUB01615MIG · Substance
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 8 mg milligram(s)
- Max total dose
- 8 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Stéphanie MALAQUIN
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Ghania BOULARIAS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 70 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire Amiens Picardie
Pôle d’Anesthésie-Réanimation, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-515722-83-00 | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults 2024-515722-83-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC NAROPEINE 2 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC NAROPEINE 7 mg et demi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC LIDOCAINE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR | 4.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-02 | France | Acceptable 2024-07-30
|
2024-07-30 |