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

Phase 4

Completed

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

• Registration Number: NCT03071601
• Lead Sponsor: Centre Hospitalier le Mans

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.

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 Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Study Start: 2017-12-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical anesthesia	Lidocaine-Prilocaine Cream 2.5-2.5%	Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5% Prilocaine applied for at least 30 minutes before laceration repair.
Subcutaneous injection anesthesia	Lidocaine 1% Epinephrine 0.005mg/mL solution	Local anesthesia by a subcutaneous injection of a solution containing 1% Lidocaine and 0.005 mg/mL Epinephrine in the minutes before laceration repair.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Centre Hospitalier Le Mans; 🇫🇷 Le Mans, France

Centre Hospitalier Universitaire Angers; 🇫🇷 Angers, France