Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-05 @ 10:48 AM
Study NCT ID:
NCT07480135
Status:
COMPLETED
Last Update Posted:
2026-03-18
First Post:
2026-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Experience Using Lidocaine Adrenaline Tetracaine (LAT) Gel Versus Lidocaine Infiltration for Laceration Repair in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D022125', 'term': 'Lacerations'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-27', 'size': 315990, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-03-14T09:52', 'hasProtocol': True}, {'date': '2020-02-28', 'size': 161710, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-03-13T09:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-14', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Need for additional anaesthesia', 'timeFrame': 'During wound preparation prior to suturing', 'description': 'Number of patients requiring additional lidocaine infiltration due to insufficient anaesthetic effect.'}, {'measure': 'Wound characteristics', 'timeFrame': 'At time of emergency department presentation', 'description': 'Description of wound location and wound length.'}], 'primaryOutcomes': [{'measure': 'Pain during suturing', 'timeFrame': 'During suturing procedure', 'description': 'Pain experienced during wound suturing measured using a 100 mm visual analogue scale (VAS).'}], 'secondaryOutcomes': [{'measure': 'Pain during anaesthetic administration', 'timeFrame': 'At time of anaesthetic administration', 'description': 'Pain experienced during administration of the anaesthetic (LAT gel application or lidocaine infiltration) measured using a visual analogue scale (VAS).'}, {'measure': 'Pain during testing of anaesthetic effectiveness', 'timeFrame': 'After waiting period for anaesthesia (30 minutes LAT gel / 5 minutes lidocaine)', 'description': 'Pain experienced during testing of anaesthetic adequacy using a needle prick, measured using a visual analogue scale (VAS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Topical anaesthesia', 'LAT gel', 'Laceration repair', 'Local anaesthesia', 'Lidocaine infiltration', 'Pain measurement', 'Emergency department', 'Adult trauma'], 'conditions': ['Lacerations', 'Wound Repair', 'Acute Traumatic Wounds', 'Pain Management']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAdult 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.', 'detailedDescription': '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.\n\nTopical 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Presentation to the emergency department with a simple laceration requiring suturing\n* Laceration length less than 7 cm\n* Ability to provide informed consent\n* Ability to report pain using a visual analogue scale (VAS)\n\nExclusion Criteria:\n\n* Suspected tendon injury or nerve injury\n* Wounds located on mucosal surfaces\n* Wounds located on ears, nose, or genital area\n* Known allergy to local anaesthetic agents\n* Pregnancy\n* Severe cardiac or pulmonary disease\n* Drug intoxication or altered mental status\n* Sedation with nitrous oxide\n* Psychiatric disorder interfering with pain reporting\n* Language barrier preventing informed consent or pain assessment'}, 'identificationModule': {'nctId': 'NCT07480135', 'briefTitle': 'Pain Experience Using Lidocaine Adrenaline Tetracaine (LAT) Gel Versus Lidocaine Infiltration for Laceration Repair in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Vrije Universiteit Brussel'}, 'officialTitle': 'Pain Experience Using Lidocaine Adrenaline Tetracaine (LAT) Gel Versus Lidocaine Infiltration for Laceration Repair in Adults: a Prospective Comparative Study in the Emergency Department', 'orgStudyIdInfo': {'id': 'EC-2020-146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAT Gel', 'description': 'Patients receive topical lidocaine-adrenaline-tetracaine (LAT) gel applied directly into the wound prior to suturing.', 'interventionNames': ['Drug: Lidocaine-Adrenaline-Tetracaine (LAT) Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine Infiltration', 'description': 'Patients receive infiltrative local anaesthesia prior to suturing.', 'interventionNames': ['Drug: Lidocaine infiltration']}], 'interventions': [{'name': 'Lidocaine-Adrenaline-Tetracaine (LAT) Gel', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['LAT Gel']}, {'name': 'Lidocaine infiltration', 'type': 'DRUG', 'description': 'Subcutaneous infiltration of lidocaine 1% is administered locally around the wound approximately 5 minutes prior to suturing.', 'armGroupLabels': ['Lidocaine Infiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Department of Emergency Medicine, Universitair Ziekenhuis Brussel, and Research Group on Emergency and Disaster Medicine', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will be available beginning 6 months following publication of the study results and will remain available for up to 5 years after publication.', 'ipdSharing': 'YES', 'description': '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).', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jonas Stiers', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}