Overview
Sponsor-declared trial summary
Respiratory disease. Prescripcion o indicación de gasometría.
To evaluate the efficacy of infiltrated mepivacaine versus placebo and nothing to reduce pain caused by arterial puncture during blood gas analysis in patients at the Pneumology Outpatient Department.
Key facts
- Sponsor
- University Of The Basque Country
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2026-01-28
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate the efficacy of infiltrated mepivacaine versus placebo and nothing to reduce pain caused by arterial puncture during blood gas analysis in patients at the Pneumology Outpatient Department.
Conditions and MedDRA coding
Respiratory disease. Prescripcion o indicación de gasometría.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Adults 18≥80 years; Present a good level of consciousness (Glasgow scale score >15); To have signed the Informed Consent Form.
Exclusion criteria 1
- Have a medical condition or difficulty communicating due to psychological disorders, dementia, speech impairment or language barrier; Obtain a Glasgow scale score <15; Being under the effect of alcohol, central nervous system depressant substances or active treatment for pain with opiates; Pregnant or lactating women; Patients whose pathological situation may interfere with the development of the study (e.g. clinical/psychological involvement, trauma to both wrists...); Patients with allergy or previous adverse reactions to amides; Obtaining an abnormal result in the Allen test; Decreased peripheral sensitivity of extremities due to any disease, such as diabetes; Raynaud's phenomenon; Previous participation in the same clinical trial; Inability to give Informed Consent; Do not accept to participate in the study after having been informed verbally and with documentation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To evaluate the efficacy of infiltrated mepivacaine versus placebo and nothing at all in reducing pain caused by an arterial puncture during blood gas analysis in patients attending the Pulmonology Outpatient Clinic at Galdakao-Usansolo Hospital.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Mepivacaina B.Braun 10 mg/ml solución inyectable
PRD12725433 · Product
- Active substance
- Mepivacaine Hydrochloride
- Substance synonyms
- CARBOCAINE HYDROCHLORIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 01 g gram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01BB03 — MEPIVACAINE
- Marketing authorisation
- 62.604
- MA holder
- B.BRAUN MEDICAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Suero Fisiológico Braun 0,9% disolvente para uso parenteral Cloruro de sodio
PRD11896749 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 mmol/kg millimole(s)/kilogram
- Max total dose
- 6 mmol/kg millimole(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 58449
- MA holder
- B.BRAUN MEDICAL, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of The Basque Country
- Sponsor organisation
- University Of The Basque Country
- Address
- Avenida Universidades 24
- City
- Bilbao
- Postcode
- 48007
- Country
- Spain
Scientific contact point
- Organisation
- University Of The Basque Country
- Contact name
- Número de teléfono: Centralita Campus Bizkaia
Public contact point
- Organisation
- University Of The Basque Country
- Contact name
- Número de teléfono: Centralita Campus Bizkaia
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 108 | 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 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo ECA Mepivacaina | 3 |
| Recruitment arrangements (for publication) | Acuerdo contratacion RECLUTAMIENTO | 1 |
| Recruitment arrangements (for publication) | FT-ASI-Aceptacion-servicios-implicados | 1 |
| Recruitment arrangements (for publication) | Modelo-compromiso-IP-para-pi-epa-GUARDABLE | 1 |
| Subject information and informed consent form (for publication) | Anexo8A-Hoja de informacion y CI + PDPersonales | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Resumen de las Caracteristicas del Producto | 1 |
| Synopsis of the protocol (for publication) | Protocolo Mepi Castellano | 1 |
| Synopsis of the protocol (for publication) | Protocolo mepi INGLES | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-23 | Spain | Acceptable 2026-01-23
|
2026-01-28 |