Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071601
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
University Hospital, Angers
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain, Acute Laceration Drug: Lidocaine-Prilocaine Cream 2.5-2.5% Drug: Lidocaine 1% Epinephrine 0.005mg/mL solution Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 2, 2019


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




Primary Outcome Measures :
  1. Maximum pain [ Time Frame: 60 minutes ]
    Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration).


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 60 minutes ]
    Patient satisfaction relating to the pain management measured on a four point Likert scale.

  2. Topical anesthesia failure rate [ Time Frame: 60 minutes ]
    Percentage of patients in the intervention group who required additional anesthesia by subcutaneous injection of Lidocaine/Epinephrine

  3. Pain management during the various stages of care [ Time Frame: 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.

  4. Management duration [ Time Frame: 60 minutes ]
    Mean duration of management between admission to the emergency department and discharge.

  5. Adverse effects [ Time Frame: 15 days ]
    Evaluation of adverse effects due to the anesthesia technique (e.g. allergic reactions) by a telephone interview 15 days after initial management

  6. Wound healing [ Time Frame: 15 days ]
    Evaluation of the quality of wound healing during a telephone interview by identifying signs of wound infection and/or wound reopening.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071601


Contacts
Layout table for location contacts
Contact: Christelle Jadeau, PD 0 (33) 2 43 43 43 43 ext 37 482 cjadeau@ch-lemans.fr
Contact: Jean-Christophe Callahan, MD 0 (33) 2 43 43 43 43 ext 37 520 jccallahan@ch-lemans.fr

Locations
Layout table for location information
France
Centre Hospitalier Universitaire Angers Recruiting
Angers, France, 49 000
Contact: Marion Lepottier Cerruti, MD    0241353637    marion.lepottier@chu-angers.fr   
Centre Hospitalier Le Mans Recruiting
Le Mans, France, 72 000
Contact: Christelle Jadeau, PD    0 (33) 2 43 43 43 43 ext 37 482    cjadeau@ch-lemans.fr   
Contact: Jean-Christophe Callahan, MD    0 (33) 2 43 43 43 43 ext 37 520    jccallahan@ch-lemans.fr   
Sponsors and Collaborators
Centre Hospitalier le Mans
University Hospital, Angers
Investigators
Layout table for investigator information
Principal Investigator: Julien Fonsegrive, MD Centre Hospitalier le Mans
Publications of Results:
Layout table for additonal information
Responsible Party: Centre Hospitalier le Mans
ClinicalTrials.gov Identifier: NCT03071601    
Other Study ID Numbers: CHM-2016-S2/04
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Centre Hospitalier le Mans:
Laceration
Suture
Topical anesthesia
Lidocaine
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Acute Pain
Lacerations
Disease Attributes
Pathologic Processes
Wounds and Injuries
Pain
Neurologic Manifestations
Lidocaine
Epinephrine
Prilocaine
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents