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AzTrials

PregnancyPhase 3NCT07212192

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

A Phase 3 study testing Lidocain spray and Sterilized saline solution in people with Pregnancy, run by Phenikaa University at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Lidocain spray and Sterilized saline solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteVietnam
Study dates
24 Nov 2025to 25 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Hanoi Obstetrics and Gynecology Hospital

    Hanoi, Hanoi, 100000

Other trials in Vietnam

About this study

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

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
Read more

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
Read the detailed description

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).

Conditions
Pregnancy
Being tested
Lidocain spray, Sterilized saline solution
Keywords
Lidocaine, IV pain, C-Section

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocain sprayDrug

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

  • Sterilized saline solutionCombination product

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

Study groups in NCT07212192
Study groupRoleWhat they receive
Group 2Placebo comparatorParticipants will be given three sprays sterilized saline solution 3 minutes before the interventionist performed the insertion of a catheter into their vein
Receives: Combination Product: Sterilized saline solution
Group 3No interventionNon intervention will be perform rather than usual care
InterventionExperimentalParticipants will be given three sprays of 10% Lidocaine (Lidocaine 10% pump spray, Egis) 3 minutes before the interventionist performed the insertion of a catheter into their vein
Receives: Drug: Lidocain spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score

    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.

    Measured: After the nurse insert the IV into the participants

Secondary outcomes (1)

  1. Adverse event

    Side effects cause by Lidocaine

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2025
  2. Study start24 Nov 2025
  3. Primary completion31 Jan 2026
  4. Study completion25 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07212192
Sponsor's protocol ID
PKA_01
Status last verified
Nov 2025
First submitted
30 Sep 2025
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Luangtangvarodom W, Pongrojpaw D, Chanthasenanont A, Pattaraarchachai J, Bhamarapravatana K, Suwannarurk K. The Efficacy of Lidocaine Spray in Pain Relief during Outpatient-Based Endometrial Sampling: A Randomized Placebo-Controlled Trial. Pain Res Treat. 2018 Oct 21;2018:1238627. doi: 10.1155/2018/1238627. eCollection 2018.

    PubMed 30420917

  • Dalvandi A, Ranjbar H, Hatamizadeh M, Rahgoi A, Bernstein C. Comparing the effectiveness of vapocoolant spray and lidocaine/procaine cream in reducing pain of intravenous cannulation: A randomized clinical trial. Am J Emerg Med. 2017 Aug;35(8):1064-1068. doi: 10.1016/j.ajem.2017.02.039. Epub 2017 Feb 27.

    PubMed 28285862

  • Kartufan FF. Padded Dressing with Lidocaine HCL for Reducing Pain during Intravenous Cannulation in Adult Patients: A Randomized Controlled Clinical Trial. Biomed Res Int. 2022 Apr 23;2022:6128557. doi: 10.1155/2022/6128557. eCollection 2022.

    PubMed 35502334

  • Datema J, Veldhuis J, Bekhof J. Lidocaine spray as a local analgesic for intravenous cannulation: a randomized clinical trial. Eur J Emerg Med. 2019 Feb;26(1):24-28. doi: 10.1097/MEJ.0000000000000496.

    PubMed 28799984

  • Basaranoglu G, Basaranoglu M, Erden V, Delatioglu H, Pekel AF, Saitoglu L. The effects of Valsalva manoeuvres on venepuncture pain. Eur J Anaesthesiol. 2006 Jul;23(7):591-3. doi: 10.1017/S0265021506000160. Epub 2006 Mar 1.

    PubMed 16507182

  • Alan N, Khorshid L. Evaluation of Efficacy of Valsalva Maneuver During Peripheral Intravenous Cannulation on Pain. Pain Manag Nurs. 2022 Apr;23(2):220-224. doi: 10.1016/j.pmn.2021.01.013. Epub 2021 Mar 9.

    PubMed 33712356

  • Hocking G, Weightman WM, Smith C, Gibbs NM, Sherrard K. Measuring the quality of anaesthesia from a patient's perspective: development, validation, and implementation of a short questionnaire. Br J Anaesth. 2013 Dec;111(6):979-89. doi: 10.1093/bja/aet284. Epub 2013 Aug 28.

    PubMed 23985532

  • Goudra BG, Galvin E, Singh PM, Lions J. Effect of site selection on pain of intravenous cannula insertion: A prospective randomised study. Indian J Anaesth. 2014 Nov-Dec;58(6):732-5. doi: 10.4103/0019-5049.147166.

    PubMed 25624538

  • Sebbane M, Claret PG, Lefebvre S, Mercier G, Rubenovitch J, Jreige R, Eledjam JJ, de La Coussaye JE. Predicting peripheral venous access difficulty in the emergency department using body mass index and a clinical evaluation of venous accessibility. J Emerg Med. 2013 Feb;44(2):299-305. doi: 10.1016/j.jemermed.2012.07.051. Epub 2012 Sep 13.

    PubMed 22981661

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lidocain spray and Sterilized saline solution in people with Pregnancy, run by Phenikaa University at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: After the nurse insert the IV into the participants). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07212192, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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