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

NCT ID: NCT07212192

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-24
• Study Completion Date: 2026-01-25

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).

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Group 2

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

Group Type: PLACEBO_COMPARATOR

Sterilized saline solution

Intervention Type: 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

Group 3

Non intervention will be perform rather than usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Participants 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

Group Type: EXPERIMENTAL

Lidocain spray

Intervention Type: DRUG

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

Interventions

Lidocain spray

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

Intervention Type: DRUG

Sterilized 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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Phenikaa University

OTHER

Sponsor Role: lead

Responsible Party

Hoang T.X Huong

Vice - Dean of Nursing Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huong Hoang, PhD

Role: PRINCIPAL_INVESTIGATOR

Phenikaa University

Central Contacts

Huong TX Hoang, Dr

Role: CONTACT

huong.hoangthixuan@phenikaa-uni.edu.vn

+84982501850

Anh Pham, Master

Role: CONTACT

lequynhtrang142@gmail.com

+8483866313

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PKA_01

Identifier Type: -

Identifier Source: org_study_id