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Testing How Well Mepivacaine Works to Reduce Pain During Arterial Puncture in Patients with Respiratory Disease Needing Blood Gas Analysis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people with respiratory disease who need to have a blood gas test, which requires taking blood from an artery. The study will test whether using mepivacaine, a medication that numbs the area where the needle is inserted, can help reduce pain during this procedure. Some participants will receive mepivacaine injected under the skin before the arterial puncture, while others will receive placebo or no treatment at all before the blood is drawn.

The purpose of the study is to find out if mepivacaine is effective in reducing the pain that patients feel when blood is taken from an artery for gas analysis. During the study, participants will be divided into different groups. One group will receive mepivacaine injected into the skin near the puncture site, another group will receive placebo, and a third group will not receive any injection before the arterial puncture. The study team will then measure and compare how much pain each group experiences during the procedure.

Participants will be adults between 18 and 80 years of age who are alert and able to understand the study. The mepivacaine will be given as a solution for injection under the skin, with a maximum dose of 200 milligrams for a single treatment session. The study will help doctors understand whether using this local anesthetic before taking arterial blood samples can make the procedure more comfortable for patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and consent

    Your consciousness level will be assessed using the Glasgow scale, which measures your awareness and responsiveness. A score greater than 15 is required to participate.

    You will be asked to sign an Informed Consent Form, which is a document explaining the study and confirming your voluntary agreement to participate.

    Your age will be verified to ensure you are between 18 and 80 years old.

  2. Step 2

    Group assignment

    You will be randomly assigned to one of three groups. This random assignment ensures that the study results are fair and unbiased.

    The first group will receive mepivacaine, which is a local numbing medication.

    The second group will receive a placebo, which is a saline solution that contains no active medication.

    The third group will receive no treatment before the procedure.

  3. Step 3

    Treatment administration

    If you are assigned to the mepivacaine group, you will receive an injection of mepivacaine hydrochloride 10 mg/ml into the skin at the site where the arterial puncture will be performed. This medication is designed to numb the area.

    If you are assigned to the placebo group, you will receive an injection of sodium chloride 0.9% (saline solution) into the skin at the same site. This solution has no numbing effect.

    If you are assigned to the no treatment group, no injection will be given before the arterial puncture.

    The injection will be given either under the skin or into a vein, depending on the procedure requirements.

  4. Step 4

    Arterial puncture for blood gas analysis

    An arterial puncture will be performed to collect a blood sample from an artery. This procedure is also called a blood gas analysis and is used to measure oxygen and carbon dioxide levels in your blood.

    The puncture will be done at the site where the treatment or placebo was administered, or at the designated site if you received no treatment.

    This procedure is necessary as part of your respiratory disease evaluation.

  5. Step 5

    Pain assessment

    After the arterial puncture, you will be asked to rate the pain level you experienced during the procedure.

    This assessment helps determine how effective the numbing medication was compared to the placebo or no treatment.

    Your response will be recorded as part of the study data.

Who can join the trial?

3 criteria

  • You must be an adult between 18 and 80 years old
  • You must have a good level of consciousness, which means you are alert and aware of your surroundings, measured by a Glasgow scale score greater than 15. The Glasgow scale is a tool that doctors use to check how awake and responsive a person is
  • You must have signed the Informed Consent Form, which is a document that explains the study and confirms you agree to take part

Who cannot join the trial?

9 criteria

  • Allergy or hypersensitivity to mepivacaine, which is a local numbing medicine used to reduce pain, or to other similar medicines called local anesthetics
  • Having an infection at the site where the needle would be inserted for the blood test
  • Taking blood-thinning medications that prevent blood from clotting properly, which could increase bleeding risk
  • Having a bleeding disorder, which means your blood does not clot normally and you may bleed more easily
  • Being pregnant or breastfeeding
  • Having severe kidney disease, which means your kidneys are not working properly to filter waste from your blood
  • Having severe liver disease, which means your liver is not working properly to process substances in your body
  • Being unable to understand or follow the study instructions
  • Currently participating in another clinical trial or research study
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Verified sites

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  • Verified

    Osakidetza

    SpainLabeaga, Spain

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Investigated drugs

Mepivacaine is a local anesthetic medication that is injected into the skin to numb a small area. In this trial, it is used to reduce pain before an arterial puncture, which is when a needle is inserted into an artery to collect blood for testing. The medication works by temporarily blocking pain signals in the area where it is injected, making the procedure more comfortable for patients.

What is already known about the treatment

Mepivacaine – Mepivacaine is a local anesthetic medication that is administered through injection directly into the tissue (infiltration) to numb a specific area before medical procedures. It works by temporarily blocking the sodium channels in nerve cells, which prevents pain signals from traveling to the brain. This medication is commonly used in clinical practice to reduce discomfort during minor surgical procedures and diagnostic tests, such as arterial punctures for blood gas analysis. Mepivacaine belongs to the amide class of local anesthetics and is valued for its intermediate duration of action and reliable pain-blocking effects.

Investigated diseases

Respiratory Disease – Respiratory disease refers to a group of conditions that affect the lungs and other parts of the breathing system. These disorders can impact the airways, lung tissue, or the muscles involved in breathing. Common symptoms include shortness of breath, coughing, wheezing, and chest tightness. The diseases can be acute, lasting a short time, or chronic, persisting for months or years. Respiratory diseases may result from infections, smoking, pollution, allergies, or genetic factors. The progression varies depending on the specific condition, ranging from mild discomfort to significant breathing difficulties that affect daily activities.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522974-35-00Protocol codeMEPIEstimated enrolment108 patientsSponsorUniversity Of The Basque Country

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