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

Primary Purpose

Pain, Acute, Laceration

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Lidocaine-Prilocaine Cream 2.5-2.5%
Lidocaine 1% Epinephrine 0.005mg/mL solution
Sponsored by
Centre Hospitalier le Mans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Laceration, Suture, Topical anesthesia, Lidocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Angers
  • Centre Hospitalier Le Mans

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Topical anesthesia

Subcutaneous injection anesthesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2017
Last Updated
March 9, 2022
Sponsor
Centre Hospitalier le Mans
Collaborators
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT03071601
Brief Title
Prospective Evaluation of Topical Analgesia for Laceration Repair in the Emergency Department
Official Title
Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier le Mans
Collaborators
University Hospital, Angers

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Laceration
Keywords
Laceration, Suture, Topical anesthesia, Lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical anesthesia
Arm Type
Experimental
Arm Description
Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5% Prilocaine applied for at least 30 minutes before laceration repair.
Arm Title
Subcutaneous injection anesthesia
Arm Type
Experimental
Arm Description
Local anesthesia by a subcutaneous injection of a solution containing 1% Lidocaine and 0.005 mg/mL Epinephrine in the minutes before laceration repair.
Intervention Type
Drug
Intervention Name(s)
Lidocaine-Prilocaine Cream 2.5-2.5%
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lidocaine 1% Epinephrine 0.005mg/mL solution
Intervention Description
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
Primary Outcome Measure Information:
Title
Maximum pain
Description
Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration).
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Patient satisfaction relating to the pain management measured on a four point Likert scale.
Time Frame
60 minutes
Title
Topical anesthesia failure rate
Description
Percentage of patients in the intervention group who required additional anesthesia by subcutaneous injection of Lidocaine/Epinephrine
Time Frame
60 minutes
Title
Pain management during the various stages of care
Description
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.
Time Frame
60 minutes
Title
Management duration
Description
Mean duration of management between admission to the emergency department and discharge.
Time Frame
60 minutes
Title
Adverse effects
Description
Evaluation of adverse effects due to the anesthesia technique (e.g. allergic reactions) by a telephone interview 15 days after initial management
Time Frame
15 days
Title
Wound healing
Description
Evaluation of the quality of wound healing during a telephone interview by identifying signs of wound infection and/or wound reopening.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Fonsegrive, MD
Organizational Affiliation
Centre Hospitalier le Mans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Angers
City
Angers
ZIP/Postal Code
49 000
Country
France
Facility Name
Centre Hospitalier Le Mans
City
Le Mans
ZIP/Postal Code
72 000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22694845
Citation
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.
Results Reference
result
PubMed Identifier
15572968
Citation
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.
Results Reference
result

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

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