NCT03071601

Brief Summary

The purpose of this study is to determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 17, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

4.1 years

First QC Date

February 17, 2017

Last Update Submit

March 9, 2022

Conditions

Pain, AcuteLaceration

Keywords

LacerationSutureTopical anesthesiaLidocaine

Outcome Measures

Primary Outcomes (1)

  • Maximum pain

    Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration).

    60 minutes

Secondary Outcomes (6)

  • Patient satisfaction

    60 minutes

  • Topical anesthesia failure rate

    60 minutes

  • Pain management during the various stages of care

    60 minutes

  • Management duration

    60 minutes

  • Adverse effects

    15 days

  • +1 more secondary outcomes

Study Arms (2)

Topical anesthesia

EXPERIMENTAL

Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5% Prilocaine applied for at least 30 minutes before laceration repair.

Drug: Lidocaine-Prilocaine Cream 2.5-2.5%

Subcutaneous injection anesthesia

EXPERIMENTAL

Local anesthesia by a subcutaneous injection of a solution containing 1% Lidocaine and 0.005 mg/mL Epinephrine in the minutes before laceration repair.

Drug: Lidocaine 1% Epinephrine 0.005mg/mL solution

Interventions

Lidocaine-Prilocaine Cream 2.5-2.5%DRUG

Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5 % Prilocaine for at least 30 minutes on and around the wound before suture

Topical anesthesia
Lidocaine 1% Epinephrine 0.005mg/mL solutionDRUG

Local anesthesia by subcutaneous injection of a solution containing 1% Lidocaine and 0.005mg/mL Epinephrine in and around the wound in the minutes preceding the suture of the wound

Subcutaneous injection anesthesia

Eligibility Criteria

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

You may qualify if:

  • Superficial skin laceration requiring a suture

You may not qualify if:

  • Known allergy to lidocaine
  • Mucous membrane or eye wound
  • Nose, ear or perineal wound
  • Active hemorrhage in the wound
  • Dirty or infected wound
  • Wound requiring operation room management
  • Distracting pain in an other location
  • Intoxicated or comatose patient
  • Patient Under guardianship
  • Contra-indication to Lidocaine/Prilocaine cream: hypersensitivity, glucose-6-phosphate deficiency, idiopathic methemoglobinemia
  • Neurologic disorder affecting pain sensitivity
  • Dementia
  • Pregnancy, breast feeding, absence of contraceptive measures for women of childbearing age
  • Absence of signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire Angers

Angers, 49 000, France

Location

Centre Hospitalier Le Mans

Le Mans, 72 000, France

Location

Related Publications (2)

  • McNulty RJ, Handley TP, Devlin MF. Reducing the need for general anaesthesia in children: use of LAT gel in treating facial lacerations. Br J Oral Maxillofac Surg. 2013 Sep;51(6):e130-1. doi: 10.1016/j.bjoms.2012.04.259. Epub 2012 Jun 12.

    PMID: 22694845RESULT

  • White NJ, Kim MK, Brousseau DC, Bergholte J, Hennes H. The anesthetic effectiveness of lidocaine-adrenaline-tetracaine gel on finger lacerations. Pediatr Emerg Care. 2004 Dec;20(12):812-5. doi: 10.1097/01.pec.0000148029.61222.9f.

    PMID: 15572968RESULT

MeSH Terms

Conditions

Acute PainLacerations

Interventions

LidocaineEpinephrineSolutions

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPharmaceutical Preparations

Study Officials

  • Julien Fonsegrive, MD

    Centre Hospitalier le Mans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2017

First Posted

March 7, 2017

Study Start

December 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)