Topical Lidocaine for Digital Nerve Block Pain

NCT07834866 | Completed Phase 4

• 1 other identifier: 2024-KAEK-020
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Finger Injuries; Procedural Pain

Keywords

Digital Nerve Block; Finger Laceration; Procedural Pain; Local Anesthesia; Lidocaine Spray

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after completion of the digital nerve block

Secondary Outcomes (2)

• Treatment-Related Adverse Events

  From intervention administration through completion of the procedure

• Change in Pain Score (ΔVAS)

  From baseline before the intervention to immediately after completion of the digital nerve block injection

Study Arms (2)

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.

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.

Drug: Placebo Spray

Interventions

Topical Lidocaine Spray DRUG

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.

Lidocaine Group

Placebo Spray DRUG

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (2)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Pursaklar State Hsopital

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

• 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

• Yildiz 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.

  PMID: 34879493 BACKGROUND

• Gur 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.

  PMID: 34098331 BACKGROUND

• Borbon 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.

  PMID: 35795710 BACKGROUND

• Jarragh 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.

  PMID: 35936956 BACKGROUND

MeSH Terms

Conditions

Finger Injuries; Pain, Procedural

Condition Hierarchy (Ancestors)

Hand Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Identical 50-mL bottles were coded as A or B by a pharmacist not involved in patient enrollment, intervention administration, or outcome assessment. Participants, clinicians performing the digital nerve block, and outcome assessors were blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Model Details: Participants are randomly assigned in a 1:1 ratio to receive topical lidocaine spray or placebo spray before digital nerve block.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 22, 2026
• Study Start: April 1, 2026
• Primary Completion: August 30, 2026
• Study Completion: September 15, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)