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Completed

NCT Number: NCT07834866

Topical Lidocaine for Digital Nerve Block Pain

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankara Bilkent City Hospital, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

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Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Treatment-Related Adverse Events

    Time frame: From intervention administration through completion of the procedure

    Treatment-related adverse events will be prospectively recorded, including local erythema, burning, edema, or other unexpected reactions at the application site.

  2. Change in Pain Score (ΔVAS)

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

    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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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