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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
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.
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.
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Pursaklar State Hsopital
Ankara, Turkey (Türkiye)
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.
Time frame: Immediately after completion of the digital nerve block
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.
Time frame: 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.
Time frame: From baseline before the intervention to immediately after completion of the digital nerve block injection
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