LacerationsPhase 4NCT07480135
Pain Experience Using Lidocaine Adrenaline Tetracaine (LAT) Gel Versus Lidocaine Infiltration for Laceration Repair in Adults
A Phase 4 study testing Lidocaine-Adrenaline-Tetracaine (LAT) Gel and Lidocaine infiltration in people with Lacerations and Wound Repair, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lacerations, Wound Repair, Acute Traumatic Wounds
- What is being tested?
- Lidocaine-Adrenaline-Tetracaine (LAT) Gel and Lidocaine infiltration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2021to 31 May 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- Drug intoxication or altered mental status
- Sedation with nitrous oxide
- Psychiatric disorder interfering with pain reporting
- Language barrier preventing informed consent or pain assessment
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Emergency Medicine, Universitair Ziekenhuis Brussel, and Research Group on Emergency and Disaster Medicine
Jette, Brussels Capital, 1090
About this study
Official title: 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.
Read the 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.
- Conditions
- Lacerations, Wound Repair, Acute Traumatic Wounds, Pain Management
- Being tested
- Lidocaine-Adrenaline-Tetracaine (LAT) Gel, Lidocaine infiltration
- Keywords
- Topical anaesthesia, LAT gel, Laceration repair, Local anaesthesia, Lidocaine infiltration, Pain measurement, Emergency department, Adult trauma
- Medical subject headings
- Lacerations, Agnosia, Emergencies, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine-Adrenaline-Tetracaine (LAT) GelDrug
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.
Lidocaine infiltrationDrug
Subcutaneous infiltration of lidocaine 1% is administered locally around the wound approximately 5 minutes prior to suturing.
| Study group | Role | What they receive |
|---|---|---|
| LAT Gel | Experimental | Patients receive topical lidocaine-adrenaline-tetracaine (LAT) gel applied directly into the wound prior to suturing. Receives: Drug: Lidocaine-Adrenaline-Tetracaine (LAT) Gel |
| Lidocaine Infiltration | Active comparator | Patients receive infiltrative local anaesthesia prior to suturing. Receives: Drug: Lidocaine infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during suturing
Pain experienced during wound suturing measured using a 100 mm visual analogue scale (VAS).
Measured: During suturing procedure
Secondary outcomes (2)
Pain during anaesthetic administration
Pain experienced during administration of the anaesthetic (LAT gel application or lidocaine infiltration) measured using a visual analogue scale (VAS).
Measured: At time of anaesthetic administration
Pain during testing of anaesthetic effectiveness
Pain experienced during testing of anaesthetic adequacy using a needle prick, measured using a visual analogue scale (VAS).
Measured: After waiting period for anaesthesia (30 minutes LAT gel / 5 minutes lidocaine)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Apr 2021
- Primary completion22 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LacerationsStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Responsible party
- Principal investigator, Jonas Stiers, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480135
- Sponsor's protocol ID
- EC-2020-146
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
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 Feb;5(2):108-12. doi: 10.1111/j.1553-2712.1998.tb02593.x.
PubMed 9492129Vandamme 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 Feb;24(1):55-59. doi: 10.1097/MEJ.0000000000000298.
PubMed 26214220Ernst 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 Aug;167(2):79-81.
PubMed 9291744
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Experience Using Lidocaine Adrenaline Tetracaine (LAT) Gel Versus Lidocaine Infiltration for Laceration Repair in Adults: a Prospective Comparative Study in the Emergency Department
- ClinicalTrials.gov ID
- NCT07480135
- Acronym / sponsor ID
- EC-2020-146
- Conditions
- Lacerations, Wound Repair, Acute Traumatic Wounds, Pain Management
- Keywords
- Topical anaesthesia, LAT gel, Laceration repair, Local anaesthesia, Lidocaine infiltration, Pain measurement, Emergency department, Adult trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 22 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| LAT Gel | Experimental | Drug: Lidocaine-Adrenaline-Tetracaine (LAT) GelPatients receive topical lidocaine-adrenaline-tetracaine (LAT) gel applied directly into the wound prior to suturing. |
| Lidocaine Infiltration | Active comparator | Drug: Lidocaine infiltrationPatients receive infiltrative local anaesthesia prior to suturing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine-Adrenaline-Tetracaine (LAT) GelLAT 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. | Drug | LAT Gel |
| Lidocaine infiltrationSubcutaneous infiltration of lidocaine 1% is administered locally around the wound approximately 5 minutes prior to suturing. | Drug | Lidocaine Infiltration |
Primary outcome
Pain during suturing
Time frame: During suturing procedure
Pain experienced during wound suturing measured using a 100 mm visual analogue scale (VAS).
2 secondary outcomes
Pain during anaesthetic administration
Time frame: At time of anaesthetic administration
Pain during testing of anaesthetic effectiveness
Time frame: After waiting period for anaesthesia (30 minutes LAT gel / 5 minutes lidocaine)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 9492129Adler 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 Feb;5(2):108-12. doi: 10.1111/j.1553-2712.1998.tb02593.x.
- Background: PubMed 26214220Vandamme 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 Feb;24(1):55-59. doi: 10.1097/MEJ.0000000000000298.
- Background: PubMed 9291744Ernst 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 Aug;167(2):79-81.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine-Adrenaline-Tetracaine (LAT) Gel and Lidocaine infiltration in people with Lacerations and Wound Repair, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during suturing (time frame: During suturing procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07480135, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.