Finger InjuriesPhase 4NCT07834866
Topical Lidocaine for Digital Nerve Block Pain
A Phase 4 study testing Topical Lidocaine Spray in people with Finger Injuries and Procedural Pain, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to determine whether topical lidocaine spray applied to the wound before digital nerve block can reduce injection-related pain in patients with finger lacerations. The study will also evaluate whether topical lidocaine spray affects the success of the nerve block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Finger Injuries, Procedural Pain
- What is being tested?
- Topical Lidocaine Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 15 Sep 2026
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older. Acute traumatic finger laceration requiring a digital nerve block as part of routine wound management.
- Digital nerve block clinically indicated for wound exploration and/or repair. Conscious and able to communicate reliably. Able to assess pain using a visual analog scale (VAS). Provision of written informed consent.
Who cannot join
- Known allergy or hypersensitivity to lidocaine or other local anesthetics. Administration of an analgesic, opioid, or sedative before the study procedure. Associated open fracture, tendon injury, digital nerve injury, or vascular injury.
- Infection or clinically evident tissue necrosis at the injured site. Peripheral neuropathy or another clinical condition potentially interfering with pain perception.
- Cognitive impairment, altered mental status, or a communication barrier preventing reliable pain assessment.
- Pregnancy or breastfeeding.
- -
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Bilkent City Hospital
Ankara, 06800
Pursaklar State Hsopital
Ankara
About this study
Official title: Topical 10% Lidocaine Spray for Reducing Injection Pain During Digital Nerve Block in Adults With Traumatic Finger Lacerations: A Randomized, Double-Blind, Placebo-Controlled, Two-Center Trial
The goal of this clinical trial is to determine whether topical lidocaine spray applied to the wound before digital nerve block can reduce injection-related pain in patients with finger lacerations. The study will also evaluate whether topical lidocaine spray affects the success of the nerve block.
The main questions it aims to answer are:
Read more
Does topical lidocaine spray reduce pain during digital nerve block injection? Does topical lidocaine spray improve first-pass success of the digital nerve block? Researchers will compare topical lidocaine spray with a placebo spray to determine whether lidocaine provides better pain control during the procedure.
Participants will:
Receive either topical lidocaine spray or placebo spray applied to the wound before the digital nerve block.
Undergo a standard digital nerve block with lidocaine. Rate their pain during the procedure. Be assessed for block success, procedure duration, satisfaction, willingness to undergo the procedure again if needed, and adverse events.
Read the detailed description
This prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluates the effect of topical lidocaine spray on pain associated with digital nerve block in patients presenting with finger lacerations. Participants are randomized to receive either topical lidocaine spray or placebo before a standardized digital nerve block. Patients, clinicians performing the block, and outcome assessors are blinded to treatment allocation. In addition to procedural pain and first-pass block success, procedure duration, patient satisfaction, willingness to undergo the procedure again, and adverse events are evaluated.
- Conditions
- Finger Injuries, Procedural Pain
- Being tested
- Topical Lidocaine Spray, Placebo Spray
- Keywords
- Digital Nerve Block, Finger Laceration, Procedural Pain, Local Anesthesia, Lidocaine Spray
- Medical subject headings
- Finger Injuries, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Lidocaine SprayDrug
Two puffs of topical lidocaine spray are applied directly to the wound area. After a 2-minute waiting period, a standardized bilateral dorsal digital nerve block is performed using a total of 3 mL of 2% lidocaine.
Placebo SprayDrug
Two puffs of placebo spray containing peppermint essence and no lidocaine are applied directly to the wound area. After a 2-minute waiting period, the same standardized bilateral dorsal digital nerve block is performed using a total of 3 mL of 2% lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Experimental | Participants receive two puffs of topical lidocaine spray applied directly to the wound area. After a 2-minute waiting period, a standardized bilateral dorsal digital nerve block is performed using a total of 3 mL of 2% lidocaine. Receives: Drug: Topical Lidocaine Spray |
| Placebo Group | Placebo comparator | Participants receive two puffs of placebo spray applied directly to the wound area. After a 2-minute waiting period, the same standardized bilateral dorsal digital nerve block is performed using a total of 3 mL of 2% lidocaine. Receives: Drug: Placebo Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Pain During Digital Nerve Block
Pain experienced during administration of the digital nerve block, assessed using a 100-mm Visual Analog Scale (VAS). The score is recorded immediately after completion of the block injection (VAS-1), with higher scores indicating greater pain.
Measured: Immediately after completion of the digital nerve block
Secondary outcomes (2)
Treatment-Related Adverse Events
Treatment-related adverse events will be prospectively recorded, including local erythema, burning, edema, or other unexpected reactions at the application site.
Measured: From intervention administration through completion of the procedure
Change in Pain Score (ΔVAS)
The difference between baseline pain and procedural pain will be calculated as ΔVAS = VAS-0 - VAS-1. VAS-0 represents pain associated with the traumatic injury before the intervention, whereas VAS-1 represents pain during digital nerve block injection.
Measured: From baseline before the intervention to immediately after completion of the digital nerve block injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Apr 2026
- Primary completion30 Aug 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Finger InjuriesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive topical lidocaine spray or placebo spray before digital nerve block.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Yenal, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834866
- Sponsor's protocol ID
- 2024-KAEK-020
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data sharing is planned.
Publications
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 28799984Yildiz IU, Yildirim C, Ozhasenekler A, Sener A, Gokhan S. Effectiveness of lidocaine spray on radial arterial puncture pain: A randomized double-blind placebo controlled trial. Am J Emerg Med. 2021 Dec;50:724-728. doi: 10.1016/j.ajem.2021.09.077. Epub 2021 Oct 1.
PubMed 34879493Gur A, Tekin E. 10% Lidocaine spray as a local anesthetic in blood gas sampling: A randomized, double-blind, placebo-controlled study. Am J Emerg Med. 2021 Nov;49:89-93. doi: 10.1016/j.ajem.2021.05.060. Epub 2021 May 28.
PubMed 34098331Borbon TY, Qu P, Coleman-Satterfield TT, Kearney R, Klein EJ. Digital nerve blocks: A systematic review and meta-analysis. J Am Coll Emerg Physicians Open. 2022 Jul 1;3(4):e12753. doi: 10.1002/emp2.12753. eCollection 2022 Aug.
PubMed 35795710Jarragh A, Lari A, Burhamah W, Alherz M, Nouri A, Alshammari Y, Al-Jasim A, AlRefai S, Alnusif N. Comparison of pain and extent of anesthesia in digital blocks for isolated finger lacerations: A randomized controlled trial. Turk J Emerg Med. 2022 Jul 1;22(3):125-130. doi: 10.4103/tjem.tjem_344_21. eCollection 2022 Jul-Sep.
PubMed 35936956
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical 10% Lidocaine Spray for Reducing Injection Pain During Digital Nerve Block in Adults With Traumatic Finger Lacerations: A Randomized, Double-Blind, Placebo-Controlled, Two-Center Trial
- ClinicalTrials.gov ID
- NCT07834866
- Acronym / sponsor ID
- 2024-KAEK-020
- Conditions
- Finger Injuries, Procedural Pain
- Keywords
- Digital Nerve Block, Finger Laceration, Procedural Pain, Local Anesthesia, Lidocaine Spray
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 22 Sep 2026 (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 determine whether topical lidocaine spray applied to the wound before digital nerve block can reduce injection-related pain in patients with finger lacerations. The study will also evaluate whether topical lidocaine spray affects the success of the nerve block.
The main questions it aims to answer are:
Does topical lidocaine spray reduce pain during digital nerve block injection? Does topical lidocaine spray improve first-pass success of the digital nerve block? Researchers will compare topical lidocaine spray with a placebo spray to determine whether lidocaine provides better pain control during the procedure.
Participants will:
Receive either topical lidocaine spray or placebo spray applied to the wound before the digital nerve block.
Undergo a standard digital nerve block with lidocaine. Rate their pain during the procedure. Be assessed for block success, procedure duration, satisfaction, willingness to undergo the procedure again if needed, and adverse events.
Detailed description
This prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluates the effect of topical lidocaine spray on pain associated with digital nerve block in patients presenting with finger lacerations. Participants are randomized to receive either topical lidocaine spray or placebo before a standardized digital nerve block. Patients, clinicians performing the block, and outcome assessors are blinded to treatment allocation. In addition to procedural pain and first-pass block success, procedure duration, patient satisfaction, willingness to undergo the procedure again, and adverse events are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive topical lidocaine spray or placebo spray before digital nerve block.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Drug: Topical Lidocaine SprayParticipants receive two puffs of topical lidocaine spray applied directly to the wound area. After a 2-minute waiting period, a standardized bilateral dorsal digital nerve block is performed using a total of 3 mL of 2% lidocaine. |
| Placebo Group | Placebo comparator | Drug: Placebo SprayParticipants receive two puffs of placebo spray applied directly to the wound area. After a 2-minute waiting period, the same standardized bilateral dorsal digital nerve block is performed using a total of 3 mL of 2% lidocaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older. Acute traumatic finger laceration requiring a digital nerve block as part of routine wound management.
- Digital nerve block clinically indicated for wound exploration and/or repair. Conscious and able to communicate reliably. Able to assess pain using a visual analog scale (VAS). Provision of written informed consent.
Key exclusion criteria (5 listed)
- Known allergy or hypersensitivity to lidocaine or other local anesthetics. Administration of an analgesic, opioid, or sedative before the study procedure. Associated open fracture, tendon injury, digital nerve injury, or vascular injury.
- Infection or clinically evident tissue necrosis at the injured site. Peripheral neuropathy or another clinical condition potentially interfering with pain perception.
- Cognitive impairment, altered mental status, or a communication barrier preventing reliable pain assessment.
- Pregnancy or breastfeeding.
- -
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 |
|---|---|---|
| Topical Lidocaine SprayTwo puffs of topical lidocaine spray are applied directly to the wound area. After a 2-minute waiting period, a standardized bilateral dorsal digital nerve block is performed using a total of 3 mL of 2% lidocaine. | Drug | Lidocaine Group |
| Placebo SprayTwo puffs of placebo spray containing peppermint essence and no lidocaine are applied directly to the wound area. After a 2-minute waiting period, the same standardized bilateral dorsal digital nerve block is performed using a total of 3 mL of 2% lidocaine. | Drug | Placebo Group |
Primary outcome
Procedural Pain During Digital Nerve Block
Time frame: Immediately after completion of the digital nerve block
Pain experienced during administration of the digital nerve block, assessed using a 100-mm Visual Analog Scale (VAS). The score is recorded immediately after completion of the block injection (VAS-1), with higher scores indicating greater pain.
2 secondary outcomes
Treatment-Related Adverse Events
Time frame: From intervention administration through completion of the procedure
Change in Pain Score (ΔVAS)
Time frame: From baseline before the intervention to immediately after completion of the digital nerve block injection
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 22 Sep 2026.
- 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 34879493Yildiz IU, Yildirim C, Ozhasenekler A, Sener A, Gokhan S. Effectiveness of lidocaine spray on radial arterial puncture pain: A randomized double-blind placebo controlled trial. Am J Emerg Med. 2021 Dec;50:724-728. doi: 10.1016/j.ajem.2021.09.077. Epub 2021 Oct 1.
- Background: PubMed 34098331Gur A, Tekin E. 10% Lidocaine spray as a local anesthetic in blood gas sampling: A randomized, double-blind, placebo-controlled study. Am J Emerg Med. 2021 Nov;49:89-93. doi: 10.1016/j.ajem.2021.05.060. Epub 2021 May 28.
- Background: PubMed 35795710Borbon TY, Qu P, Coleman-Satterfield TT, Kearney R, Klein EJ. Digital nerve blocks: A systematic review and meta-analysis. J Am Coll Emerg Physicians Open. 2022 Jul 1;3(4):e12753. doi: 10.1002/emp2.12753. eCollection 2022 Aug.
- Background: PubMed 35936956Jarragh A, Lari A, Burhamah W, Alherz M, Nouri A, Alshammari Y, Al-Jasim A, AlRefai S, Alnusif N. Comparison of pain and extent of anesthesia in digital blocks for isolated finger lacerations: A randomized controlled trial. Turk J Emerg Med. 2022 Jul 1;22(3):125-130. doi: 10.4103/tjem.tjem_344_21. eCollection 2022 Jul-Sep.
- Individual participant dataSharing planned: No. No individual participant data sharing is planned.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical Lidocaine Spray in people with Finger Injuries and Procedural Pain, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
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 2 inclusion and 5 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Procedural Pain During Digital Nerve Block (time frame: Immediately after completion of the digital nerve block). 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 NCT07834866, which also lists 5 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 22 Sep 2026.