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Study on Reducing Pain During IV Catheter Insertion in Adult Women Using 10% Lidocaine Spray

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What is this trial about?

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

This clinical trial is focused on studying the effectiveness of a treatment to reduce pain during the insertion of a peripheral intravenous catheter (PIVC) in adult women. The study involves the use of a medication called lidocaine, which is applied as a 10% spray. Lidocaine is a local anesthetic, meaning it helps numb the area where it is applied to reduce pain. The trial aims to see if using this spray can lessen the pain experienced when a needle is inserted into a vein, which is a common procedure in medical settings.

Participants in the study will receive either the lidocaine spray or a placebo before the catheter is inserted. The main goal is to measure the level of pain felt by participants using a simple pain scale, known as the Numerical Rating Scale (NRS), which allows individuals to rate their pain on a scale from 0 to 10. The study will specifically look at pain levels in two areas: the back of the hand and the forearm. By comparing the pain levels between those who receive the lidocaine spray and those who receive the placebo, researchers hope to determine the effectiveness of the spray in reducing pain.

The trial will be conducted in a controlled and randomized manner, meaning participants will be randomly assigned to receive either the lidocaine spray or the placebo, and neither the participants nor the researchers will know which treatment is being given until the study is completed. This approach helps ensure that the results are unbiased and reliable. The study is expected to provide valuable insights into pain management during routine medical procedures, potentially improving the comfort and experience for patients undergoing similar treatments in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide consent to participate in the study.

  2. Step 2

    Initial assessment

    You will undergo an initial assessment to confirm eligibility. This includes verifying that you are a female volunteer aged 18-45 years with a personal history of having a venipuncture or insertion of a peripheral intravenous catheter (PIVC).

  3. Step 3

    Application of medication

    A **10% lidocaine spray** will be applied to the area where the PIVC will be inserted. This is to reduce pain during the procedure. The spray is used on the skin (cutaneous use) and is applied shortly before the insertion.

  4. Step 4

    Insertion of PIVC

    A healthcare professional will insert the PIVC into your hand or forearm. The pain experienced during this process will be measured using a Numerical Rating Scale (NRS), which is a simple method for you to rate your pain on a scale from 0 to 10.

  5. Step 5

    Pain assessment

    You will be asked to rate the pain caused by the PIVC insertion separately for the back of the hand and the forearm. This helps in understanding the effectiveness of the lidocaine spray in reducing pain.

  6. Step 6

    Follow-up and feedback

    After the procedure, you may be asked to provide feedback on your experience and any anticipated pain or difficulty during the PIVC insertion. This information is important for evaluating the success of the trial.

Who can join the trial?

3 criteria

  • Participants must be female.
  • Participants must be between 18 and 45 years old.
  • Participants must have a personal history of having had a venipuncture (a procedure where a needle is used to take blood from a vein) or insertion of a PIVC (a small tube placed into a vein to give medicines or fluids).

Who cannot join the trial?

4 criteria

  • Only females can participate in this study. Males are not eligible.
  • Participants must be at least 18 years old.
  • Individuals with any condition that might interfere with the study's results cannot participate.
  • Participants must not be part of any vulnerable population, which means they should not be in a situation where they might feel pressured to join the study.
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Investigated drugs

Lidocaine Spray is a medication used to numb a specific area of the body. In this clinical trial, a 10% lidocaine spray is applied to the skin before inserting a needle into a vein. The purpose of using this spray is to reduce the pain that people might feel when a needle is inserted into their skin. By numbing the area, the spray helps make the procedure more comfortable for patients. This trial specifically looks at how well the spray works on different parts of the hand and arm.

What is already known about the treatment

Lidocaine – Lidocaine is administered as a 10% spray and is used to reduce pain during the insertion of a peripheral intravenous catheter in adults. It is currently being studied in clinical trials to assess its effectiveness in minimizing pain, as measured by a pain scale. The main therapeutic use of lidocaine in this context is pain relief. At the molecular level, lidocaine works by blocking sodium channels in nerve cells, which prevents the transmission of pain signals. It is classified as a local anesthetic, meaning it numbs a specific area of the body to relieve pain.

Investigated diseases

Pain – Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. It can be acute, lasting for a short duration, or chronic, persisting over a longer period. Pain progresses through various stages, starting with the initial sensation, followed by the perception of pain intensity and quality. It can be influenced by psychological factors, such as mood and attention, which may alter the perception of pain. The experience of pain can vary greatly among individuals, depending on factors like the cause, location, and individual pain threshold. Over time, pain can lead to changes in behavior and physical function, impacting daily activities and quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507859-29-00Protocol codeV 1.0, 23AUG2023Estimated enrolment40 patientsSponsorOrdensklinikum Linz GmbH

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