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临床试验/NCT07480135
NCT07480135已完成4 期

Pain Experience Using Lidocaine Adrenaline Tetracaine (LAT) Gel Versus Lidocaine Infiltration for Laceration Repair in Adults: a Prospective Comparative Study in the Emergency Department

Vrije Universiteit Brussel1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年4月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Pain during suturing

研究概览

简要总结

This prospective comparative study evaluates pain experience in adult patients undergoing laceration repair in the emergency department using either topical lidocaine-adrenaline-tetracaine (LAT) gel or lidocaine infiltration as local anaesthesia. Lidocaine infiltration is the standard anaesthetic technique for wound repair but can cause significant pain during injection. LAT gel is a needle-free topical anaesthetic that is widely used in paediatric patients but has been less studied in adults.

Adult patients presenting with simple lacerations requiring suturing are allocated to receive either LAT gel or lidocaine infiltration according to the clinical judgement of the treating physician. Pain is measured using a visual analogue scale (VAS) during anaesthetic administration, during testing of anaesthetic effectiveness, and during suturing. Additional variables include wound characteristics, patient characteristics, and the need for additional anaesthesia. The study aims to evaluate whether LAT gel provides comparable pain control while reducing pain during anaesthetic administration.

详细描述

Pain management is an important component of wound treatment in the emergency department. Local anaesthesia is routinely required for laceration repair, most commonly using infiltrative anaesthesia with lidocaine. Although effective, lidocaine infiltration can cause significant discomfort due to the injection itself and may increase patient anxiety. In addition, infiltration can sometimes distort tissue and potentially complicate the suturing procedure. Alternative approaches that reduce pain during anaesthetic administration may therefore improve patient comfort during wound management.

Topical anaesthesia using lidocaine-adrenaline-tetracaine (LAT) gel represents a needle-free alternative to infiltrative anaesthesia. LAT gel is commonly used in paediatric patients and has demonstrated effectiveness in reducing pain during laceration repair. However, evidence regarding its use in adult patients remains limited. Evaluating the effectiveness of LAT gel in adults may help determine whether it can be used more broadly as an alternative to injection-based anaesthesia in the emergency department.

This prospective comparative study includes adult patients presenting to the emergency department of Universitair Ziekenhuis Brussel with simple lacerations requiring suturing. Patients receive either LAT gel or lidocaine infiltration as local anaesthesia according to the clinical judgement of the attending physician. Pain experience is measured using a visual analogue scale (VAS) during anaesthetic administration, during testing of anaesthetic adequacy, and during suturing. Additional variables recorded include patient characteristics, wound characteristics, suturing characteristics, the need for additional anaesthesia, and procedure-related complications. The aim of the study is to compare pain experience between both anaesthetic techniques and to assess whether LAT gel may represent a suitable alternative for selected adult lacerations.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Presentation to the emergency department with a simple laceration requiring suturing
  • Laceration length less than 7 cm
  • Ability to provide informed consent
  • Ability to report pain using a visual analogue scale (VAS)

排除标准

  • Suspected tendon injury or nerve injury
  • Wounds located on mucosal surfaces
  • Wounds located on ears, nose, or genital area
  • Known allergy to local anaesthetic agents
  • Pregnancy
  • Severe cardiac or pulmonary disease
  • Drug intoxication or altered mental status
  • Sedation with nitrous oxide
  • Psychiatric disorder interfering with pain reporting
  • Language barrier preventing informed consent or pain assessment

研究组 & 干预措施

LAT Gel

Experimental

Patients receive topical lidocaine-adrenaline-tetracaine (LAT) gel applied directly into the wound prior to suturing.

干预措施: Lidocaine-Adrenaline-Tetracaine (LAT) Gel (Drug)

Lidocaine Infiltration

Active Comparator

Patients receive infiltrative local anaesthesia prior to suturing.

干预措施: Lidocaine infiltration (Drug)

结局指标

主要结局

Pain during suturing

时间窗: During suturing procedure

Pain experienced during wound suturing measured using a 100 mm visual analogue scale (VAS).

次要结局

  • Pain during anaesthetic administration(At time of anaesthetic administration)
  • Pain during testing of anaesthetic effectiveness(After waiting period for anaesthesia (30 minutes LAT gel / 5 minutes lidocaine))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonas Stiers

MD

Vrije Universiteit Brussel

研究点 (1)

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