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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Procedural Pain During Digital Nerve Block
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Lidocaine Group
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.
干预措施: Topical Lidocaine Spray (Drug)
Placebo Group
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.
干预措施: Placebo Spray (Drug)
结局指标
主要结局
Procedural Pain During Digital Nerve Block
时间窗: 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.
次要结局
- 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)
研究者
Kadir Yenal
Specialist
Ankara City Hospital Bilkent