Overview
Sponsor-declared trial summary
Disminuir dolor en cirugía de mama
Demostrar que la infiltración intraoperatoria de lidocaína al 0.5% en la incisión quirúrgica, disminuye la incidencia de dolor agudo postoperatorio 2. Demostrar que la infiltración intraoperatoria de lidocaína al 0.5% disminuye los requerimientos de analgesia postoperatoria, especialmente de opiáceos
Key facts
- Sponsor
- Consorci Sanitari Integral
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2025-02-11
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521162-10-00
- EudraCT number
- 2022-000172-19
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Demostrar que la infiltración intraoperatoria de lidocaína al 0.5% en la incisión quirúrgica, disminuye la incidencia de dolor agudo postoperatorio 2. Demostrar que la infiltración intraoperatoria de lidocaína al 0.5% disminuye los requerimientos de analgesia postoperatoria, especialmente de opiáceos
Conditions and MedDRA coding
Disminuir dolor en cirugía de mama
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Mujer mayor de 18 años, diagnosticada de neoplasia maligna de mama, candidata a tratamiento quirúrgico programado en nuestro centro, Consorci Sanitari Integral, y que hayan firmado el consentimiento informado
Exclusion criteria 1
- -Alergia al anestésico local lidocaína -Antecedente de cirugía mamaria, torácica o de extremidad superior -Cirugía de recidiva del cáncer de mama -Dolor preoperatorio de la zona a intervenir -Alteración neurológica previa de la pared torácica -Antecedente de accidente cerebrovascular con afectación de la extremidad superior ipsilateral a la cirugía -Dificultad idiomática
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Dolor agudo postoperatorio a la 1, 4, 12, 24 y 48h postoperatorias (escala EVA), en reposo y en movimiento con la abducción del brazo > 90º
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD767982 · Product
- Active substance
- Lidocaine Hydrochloride
- Substance synonyms
- 2-DIETHYLAMINO-N-(2,6-DIMETHYLPHENYL)ACETAMIDE HYDROCHLORIDE, LIGNOCAINE HYDROCHLORIDE
- Pharmaceutical form
- INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- 6368154.00.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Consorci Sanitari Integral
- Sponsor organisation
- Consorci Sanitari Integral
- Address
- Avinguda De Josep Molins 29-41
- City
- L'hospitalet De Llobregat
- Postcode
- 08906
- Country
- Spain
Scientific contact point
- Organisation
- Consorci Sanitari Integral
- Contact name
- Puri Regueiro
Public contact point
- Organisation
- Consorci Sanitari Integral
- Contact name
- Puri Regueiro
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 128 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo version 3_26_09_2002_LIMPIO | 1 |
| Recruitment arrangements (for publication) | 9 DOCUMENTO PROCEDIMIENTO DE RECLUTAMIENTO | 1 |
| Subject information and informed consent form (for publication) | HIP+CI_Version 3_26_09_2022_LIMPIO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 10 Ficha tecnica LIDOCAINA | 1 |
| Synopsis of the protocol (for publication) | Resumen Protocolo_Version 3_26_09_2022 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-11 | Spain | Acceptable 2025-02-11
|
2025-02-11 |