Finger Injuries, Procedural Pain
Conditions
Keywords
Digital Nerve Block, Finger Laceration, Procedural Pain, Local Anesthesia, Lidocaine Spray
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.
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.
Interventions
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.
DRUGPlacebo Spray
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.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants are randomly assigned in a 1:1 ratio to receive topical lidocaine spray or placebo spray before digital nerve block.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Pain During Digital Nerve Block | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Related Adverse Events | 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. |
| Change in Pain Score (ΔVAS) | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed