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.
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.
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Lidocain spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted8 Oct 2025
- Study start24 Nov 2025
- Primary completion31 Jan 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Phenikaa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoang T.X Huong, Phenikaa University
- Investigators
- Huong Hoang, PhD, Principal investigator, Phenikaa University
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 30420917Dalvandi 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 28285862Kartufan 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 35502334Datema 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 28799984Basaranoglu 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 16507182Alan 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 33712356Hocking 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 23985532Goudra 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 25624538Sebbane 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of 10% Lidocaine Spray on Relieving Local Pain Caused by Intravenous (IV) Intubation: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07212192
- Acronym / sponsor ID
- PKA_01
- Conditions
- Pregnancy
- Keywords
- Lidocaine, IV pain, C-Section
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Phenikaa UniversityUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Placebo comparator | Combination Product: Sterilized saline solutionParticipants will be given three sprays sterilized saline solution 3 minutes before the interventionist performed the insertion of a catheter into their vein |
| Group 3 | No intervention | –Non intervention will be perform rather than usual care |
| Intervention | Experimental | Drug: Lidocain sprayParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who were emergency cases for going to a C-section delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocain sprayApplying 3 spray of 10% Lidocaine to the IV insertion site in women before their C-section | Drug | Intervention |
| Sterilized saline solutionParticipants will be given three sprays sterilized saline solution 3 minutes before the interventionist performed the insertion of a catheter into their vein | Combination product | Group 2 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 30420917Luangtangvarodom 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.
- Background: PubMed 28285862Dalvandi 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.
- Background: PubMed 35502334Kartufan 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.
- Background: PubMed 28799984Datema 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.
- Background: PubMed 16507182Basaranoglu 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.
- Background: PubMed 33712356Alan 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.
- Background: PubMed 23985532Hocking 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.
- Background: PubMed 25624538Goudra 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.
- Background: PubMed 22981661Sebbane 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huong Hoang, PhD principal investigator
Phenikaa University
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.