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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Acute, Laceration

Intervention / Treatment
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* Drug: Lidocaine-Prilocaine Cream 2.5-2.5%
* Drug: Lidocaine 1% Epinephrine 0.005mg/mL solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical anesthesia<br>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%<br>* 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<br>|
| Experimental: Subcutaneous injection anesthesia<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laceration, Suture, Topical anesthesia, Lidocaine