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NCT Number: NCT07212192

Effectiveness of 10% Lidocaine on Relieving Pain Caused by Intravenous Intubation

The goal of this clinical trial is to learn if 10% Lidocaine spray can reduce local pain caused by intravenous (IV) intubation among women. The main questions it aims to answer are:

* Does 10% Lidocaine spray lower the VAS score in participants need intravenous intubation? * What size effect of 10% Lidocaine spray when patients administered? Researchers will compare 10% Lidocaine spray to a placebo (a look-alike substance that contains no drug) to see if 10% Lidocaine spray works to reduce local pain caused by intravenous (IV) intubation

Participants will:

* Receive 3 spray of 10% Lidocaine at intravenous catheter insertion site before the nurse perform the IV insert procedure * Assess the pain cause by IV insertion using VAS

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

Intravenous (IV) cannulation is a technique in which a cannula is placed inside a vein through the patient's skin. It is the most commonly performed procedure in clinical settings. Nevertheless, it is also the second most painful procedure that significantly elevates a patient's anxiety levels. IV is required for every patient before their operation. Managing this pre-operative pain has been listed as an indicator of the quality of anesthesia. As such, various interventions have been conducted to reduce the pain caused by intravenous intubation among patients. Non-pharmacological approaches to reduce this pain include using the flash of light to distract patients, cough tricks, Valsalva manoeuvers, and vapor coolant spray, essential oil . Pharmacological approaches for reducing local pain caused by IV include Lidocaine cream/patch/spray, EMLA (mixture of Lidocaine and Prilocain), diclofenac transdermal, and Piroxicam gel . However, none of these methods exhibited a clear superiority over the others. There is no clear consensus about which method is the best option to relieve pain induced by IV. Among pharmacological approaches, using Lidocaine provides some promising results in reducing pain related to IV insertion. Among the different dosage forms, Lidocaine spray is the most convenient with a fast effect. It is quickly absorption within 1 to 5 minutes. However, inconsistent results have been reported regarding this application . Notably, previous trials conducted in different populations, ages, settings, and needle sizes somewhat cause bias in the results. As such, more trials with rigorous design should be implemented to provide strong evidence to support the role of Lidocaine spray in reducing local paint caused by IV intubation. The objective of this study was to evaluate the effect of Lidocaine spray on relieving local pain caused by intravenous intubation. To ensure a homogeneous population, we chose the participants who were women before their Cesarean section delivery (C-section).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria comprised participants who were going to undergo a scheduled C-section delivery
  • Over 18 years old
  • Able to read and write Vietnamese.
  • Sign the consent form

Exclusion criteria

  • Participants who were emergency cases for going to a C-section delivery

Treatment and study plan

Lidocain spray

Drug

Applying 3 spray of 10% Lidocaine to the IV insertion site in women before their C-section

Sterilized saline solution

Combination Product

Participants will be given three sprays sterilized saline solution 3 minutes before the interventionist performed the insertion of a catheter into their vein

Primary outcomes

  1. Pain score

    Time frame: After the nurse insert the IV into the participants

    The Pain score will be measured by a visual analog scale (VAS). This is a validated, subjective measure of pain. It is typically a 10-cm line, used to assess a person's perception of pain, discomfort, or other subjective feelings by having them mark a point on the line that best represents their experience. It ranged from 0 to 10, with 0 meaning "no pain" and 10 meaning "worst pain ever". The greater score, indicate greater pain.

Secondary outcomes

  1. Adverse event

    Time frame: List any side effect of Lidocaine reported by participant or observed by PI within 2 hours after the IV has been inserted

    Side effects cause by Lidocaine

Study contacts

Contact information is provided by the study sponsor or research team.

Anh Pham, Master

CONTACT

[email protected]

+8483866313

Huong TX Hoang, Dr

CONTACT

[email protected]

+84982501850

Sponsors and collaborators

Lead sponsor

Phenikaa University

Other

Registry information

Official study title

Effectiveness of 10% Lidocaine Spray on Relieving Local Pain Caused by Intravenous (IV) Intubation: a Randomized Control Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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