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

NCT07212192 | Not Yet Recruiting Phase 3

• 1 other identifier: PKA_01
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pregnancy

Keywords

Lidocaine; IV pain; C-Section

Outcome Measures

Primary Outcomes (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.

  After the nurse insert the IV into the participants

Secondary Outcomes (1)

• Adverse event

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

Study Arms (3)

Group 2

PLACEBO COMPARATOR

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

Combination Product: Sterilized saline solution

Group 3

NO INTERVENTION

Non intervention will be perform rather than usual care

Intervention

EXPERIMENTAL

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

Drug: Lidocain spray

Interventions

Lidocain spray DRUG

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

Intervention

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old
• Able to read and write Vietnamese.
• Sign the consent form

You may not qualify if:

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

Sponsors & Collaborators

• Phenikaa University: lead

Related Publications (9)

• 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.

  PMID: 30420917 BACKGROUND

• 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.

  PMID: 28285862 BACKGROUND

• 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.

  PMID: 35502334 BACKGROUND

• 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.

  PMID: 28799984 BACKGROUND

• 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.

  PMID: 16507182 BACKGROUND

• 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.

  PMID: 33712356 BACKGROUND

• 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.

  PMID: 23985532 BACKGROUND

• 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.

  PMID: 25624538 BACKGROUND

• 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.

  PMID: 22981661 BACKGROUND

Study Officials

• Huong Hoang, PhD

  Phenikaa University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huong TX Hoang, Dr

CONTACT

+84982501850; huong.hoangthixuan@phenikaa-uni.edu.vn

Anh Pham, Master

CONTACT

+8483866313; lequynhtrang142@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice - Dean of Nursing Faculty

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: November 24, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 25, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11