NCT07480135

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 14, 2026

Last Update Submit

March 14, 2026

Conditions

Keywords

Topical anaesthesiaLAT gelLaceration repairLocal anaesthesiaLidocaine infiltrationPain measurementEmergency departmentAdult trauma

Outcome Measures

Primary Outcomes (1)

  • Pain during suturing

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

    During suturing procedure

Secondary Outcomes (2)

  • 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)

Other Outcomes (2)

  • Need for additional anaesthesia

    During wound preparation prior to suturing

  • Wound characteristics

    At time of emergency department presentation

Study Arms (2)

LAT Gel

EXPERIMENTAL

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

Drug: Lidocaine-Adrenaline-Tetracaine (LAT) Gel

Lidocaine Infiltration

ACTIVE COMPARATOR

Patients receive infiltrative local anaesthesia prior to suturing.

Drug: Lidocaine infiltration

Interventions

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.

LAT Gel

Subcutaneous infiltration of lidocaine 1% is administered locally around the wound approximately 5 minutes prior to suturing.

Lidocaine Infiltration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Emergency Medicine, Universitair Ziekenhuis Brussel, and Research Group on Emergency and Disaster Medicine

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (3)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

LacerationsAgnosiaEmergenciesWounds and Injuries

Interventions

Gels

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective comparative study conducted in the emergency department of Universitair Ziekenhuis Brussel. Adult patients with simple lacerations requiring suturing receive either topical lidocaine-adrenaline-tetracaine (LAT) gel or lidocaine infiltration based on the clinical judgement of the attending physician.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 14, 2026

First Posted

March 18, 2026

Study Start

April 1, 2021

Primary Completion

May 22, 2021

Study Completion

May 31, 2021

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this study, after de-identification, may be shared upon reasonable request. Shared data may include demographic characteristics, wound characteristics, treatment allocation, and pain scores measured using the visual analogue scale (VAS).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be available beginning 6 months following publication of the study results and will remain available for up to 5 years after publication.
Access Criteria
Data will be available to researchers who provide a methodologically sound proposal for secondary analyses. Proposals should be directed to the corresponding author. Access will be granted after review and approval by the study investigators and the institutional review board when required. Data will be shared in a de-identified format in accordance with institutional and data protection regulations.

Locations