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

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07212192
Enrollment
150
Registered
2025-10-08
Start date
2025-11-24
Completion date
2026-01-25
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Lidocaine, IV pain, C-Section

Brief 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 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

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).

Interventions

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

COMBINATION_PRODUCTSterilized saline solution

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

Sponsors

Phenikaa University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain scoreAfter the nurse insert the IV into the participantsThe 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

MeasureTime frameDescription
Adverse eventList any side effect of Lidocaine reported by participant or observed by PI within 2 hours after the IV has been insertedSide effects cause by Lidocaine

Contacts

Primary ContactHuong TX Hoang, Dr
huong.hoangthixuan@phenikaa-uni.edu.vn+84982501850
Backup ContactAnh Pham, Master
lequynhtrang142@gmail.com+8483866313

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026