- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07480135
Pain Experience Using Lidocaine Adrenaline Tetracaine (LAT) Gel Versus Lidocaine Infiltration for Laceration Repair in Adults
Pain Experience Using Lidocaine Adrenaline Tetracaine (LAT) Gel Versus Lidocaine Infiltration for Laceration Repair in Adults: a Prospective Comparative Study in the Emergency Department
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Brussels Capital
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Jette, Brussels Capital, Belgium, 1090
- Department of Emergency Medicine, Universitair Ziekenhuis Brussel, and Research Group on Emergency and Disaster Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: LAT Gel
Patients receive topical lidocaine-adrenaline-tetracaine (LAT) gel applied directly into the wound prior to suturing.
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LAT gel (lidocaine 4%, adrenaline 0.1%, tetracaine 0.5%) is applied directly into the wound at a dose of approximately 0.5 mL per centimetre of wound length and covered with an occlusive dressing for 30 minutes prior to suturing.
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Active Comparator: Lidocaine Infiltration
Patients receive infiltrative local anaesthesia prior to suturing.
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Subcutaneous infiltration of lidocaine 1% is administered locally around the wound approximately 5 minutes prior to suturing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain during suturing
Time Frame: During suturing procedure
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Pain experienced during wound suturing measured using a 100 mm visual analogue scale (VAS).
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During suturing procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain during anaesthetic administration
Time Frame: At time of anaesthetic administration
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Pain experienced during administration of the anaesthetic (LAT gel application or lidocaine infiltration) measured using a visual analogue scale (VAS).
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At time of anaesthetic administration
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Pain during testing of anaesthetic effectiveness
Time Frame: After waiting period for anaesthesia (30 minutes LAT gel / 5 minutes lidocaine)
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Pain experienced during testing of anaesthetic adequacy using a needle prick, measured using a visual analogue scale (VAS).
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After waiting period for anaesthesia (30 minutes LAT gel / 5 minutes lidocaine)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Need for additional anaesthesia
Time Frame: During wound preparation prior to suturing
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Number of patients requiring additional lidocaine infiltration due to insufficient anaesthetic effect.
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During wound preparation prior to suturing
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Wound characteristics
Time Frame: At time of emergency department presentation
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Description of wound location and wound length.
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At time of emergency department presentation
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Adler AJ, Dubinisky I, Eisen J. Does the use of topical lidocaine, epinephrine, and tetracaine solution provide sufficient anesthesia for laceration repair? Acad Emerg Med. 1998;5(2):108-12.
- Vandamme E, Lemoyne S, van der Gucht A, de Cock P, van de Voorde P. LAT gel for laceration repair in the emergency department: not only for children? Eur J Emerg Med. 2017;24(1):55-9.
- Ernst AA, Marvez-Valls E, Nick TG, Mills T, Minvielle L, Houry D. Topical lidocaine adrenaline tetracaine (LAT gel) versus injectable buffered lidocaine for local anesthesia in laceration repair. West J Med. 1997;167(2):79-81.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Pathologic Processes
- Disease Attributes
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Emergencies
- Wounds and Injuries
- Agnosia
- Lacerations
- Pharmaceutical Preparations
- Dosage Forms
- Complex Mixtures
- Colloids
- Gels
Other Study ID Numbers
- EC-2020-146
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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