Clinical trial • Not applicable • Respiratory

MEPIVACAINE HYDROCHLORIDE for Respiratory disease

Not applicable trial of MEPIVACAINE HYDROCHLORIDE for Respiratory disease.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Respiratory disease
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-09-2025
First CTIS Authorization Date
28-01-2026

Trial design

Randomised, placebo: suero fisiológico braun 0,9% (sodium chloride) solution for injection; no intervention arm ('nothing at all'). investigational product: mepivacaina b.braun 10 mg/ml solution for injection (product record shows max total dose 200 mg). schedule/dosing regimen not specified in ctis record.-controlled Not applicable trial across 1 site in Spain.

Randomised
Yes
Comparator
Placebo: Suero Fisiológico Braun 0,9% (sodium chloride) solution for injection; No intervention arm ('nothing at all'). Investigational product: Mepivacaina B.Braun 10 mg/ml solution for injection (product record shows max total dose 200 mg). Schedule/dosing regimen not specified in CTIS record.
Target Sample Size
108

Eligibility

Recruits 108 Not a vulnerable population selected. Participants are adults (18–80); 'Inability to give Informed Consent' is listed as an exclusion. Signed Informed Consent Form is required for participation..

Pregnancy Exclusion
Pregnant or lactating women
Vulnerable Population
Not a vulnerable population selected. Participants are adults (18–80); 'Inability to give Informed Consent' is listed as an exclusion. Signed Informed Consent Form is required for participation.

Inclusion criteria

  • {"criterion_text":"- Adults 18≥80 years"}
  • {"criterion_text":"- Present a good level of consciousness (Glasgow scale score >15)"}
  • {"criterion_text":"- To have signed the Informed Consent Form."}

Exclusion criteria

  • {"criterion_text":"- Have a medical condition or difficulty communicating due to psychological disorders, dementia, speech impairment or language barrier"}
  • {"criterion_text":"- Obtain a Glasgow scale score <15"}
  • {"criterion_text":"- Being under the effect of alcohol, central nervous system depressant substances or active treatment for pain with opiates"}
  • {"criterion_text":"- Pregnant or lactating women"}
  • {"criterion_text":"- Patients whose pathological situation may interfere with the development of the study (e.g. clinical/psychological involvement, trauma to both wrists...)"}
  • {"criterion_text":"- Patients with allergy or previous adverse reactions to amides"}
  • {"criterion_text":"- Obtaining an abnormal result in the Allen test"}
  • {"criterion_text":"- Decreased peripheral sensitivity of extremities due to any disease, such as diabetes"}
  • {"criterion_text":"- Raynaud's phenomenon"}
  • {"criterion_text":"- Previous participation in the same clinical trial"}
  • {"criterion_text":"- Inability to give Informed Consent"}
  • {"criterion_text":"- Do not accept to participate in the study after having been informed verbally and with documentation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
108
Recruitment Window Months
38
Consent Approach
Signed informed consent required from participants (Inclusion: 'To have signed the Informed Consent Form'). Participants unable to give informed consent are excluded. Subject information and informed consent form documents are listed in the CTIS documents. No assent process or additional language details specified.

Geography

Total Number Of Sites
1
Total Number Of Participants
108

Spain

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
64
Number Of Sites
1
Number Of Participants
108

Sites

Site Name
Osakidetza
Department Name
Enfermería
Contact Person Name
Izaskun Reyes Peñafiel
Contact Person Email
izaskun.reyes@ehu.eus

Sponsor

Primary sponsor

Full Name
University Of The Basque Country
Organisation Type
Educational Institution
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Mepivacaina B.Braun 10 mg/ml solución inyectable
Active Substance
MEPIVACAINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketing authorisation number 62.604 in Spain)
Maximum Dose
200 mg
Investigational Product Name
Suero Fisiológico Braun 0,9% disolvente para uso parenteral Cloruro de sodio
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation number 58449 in Spain)
Maximum Dose
6 mmol/kg

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