Prospective Evaluation of Topical Analgesia for Laceration Repair in the Emergency Department

Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Laceration
• Intervention / Treatment: Drug: Lidocaine-Prilocaine Cream 2.5-2.5%; Drug: Lidocaine 1% Epinephrine 0.005mg/mL solution

Detailed Description

A prospective randomized open clinical trial conducted in two high volume emergency departments in France.

Adult patients presenting for laceration repair by suture will be allocated, after consent is obtained, on a one to one basis using a randomisation by minimisation method.

126 patients are expected to enrol in the study.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Angers, France, 49 000
    • Centre Hospitalier Universitaire Angers
  • Le Mans, France, 72 000
    • Centre Hospitalier Le Mans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Superficial skin laceration requiring a suture

Exclusion Criteria:

• 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
• Inclusion in an other interventional clinical protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical anesthesia; 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%; 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
Experimental: Subcutaneous injection anesthesia; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum pain	Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration).	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction relating to the pain management measured on a four point Likert scale.	60 minutes
Topical anesthesia failure rate	Percentage of patients in the intervention group who required additional anesthesia by subcutaneous injection of Lidocaine/Epinephrine	60 minutes
Pain management during the various stages of care	Maximum pain measured on the numerical pain scale (0-10) measured on admission to the emergency department, during the wait for laceration treatment, during the wound cleansing for the intervention group and during anesthesia for the control group, during suture.	60 minutes
Management duration	Mean duration of management between admission to the emergency department and discharge.	60 minutes
Adverse effects	Evaluation of adverse effects due to the anesthesia technique (e.g. allergic reactions) by a telephone interview 15 days after initial management	15 days
Wound healing	Evaluation of the quality of wound healing during a telephone interview by identifying signs of wound infection and/or wound reopening.	15 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans
• Collaborators: University Hospital, Angers
• Investigators: Principal Investigator: Julien Fonsegrive, MD, Centre Hospitalier Le Mans

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Lidocaine; Suture; Topical anesthesia; Laceration
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Wounds and Injuries; Disease Attributes; Emergencies; Acute Pain; Lacerations; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Anesthetics, Combined; Vasoconstrictor Agents; Mydriatics; Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination; Epinephrine
• Other Study ID Numbers: CHM-2016-S2/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No