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Completed

NCT Number: NCT03071601

Prospective Evaluation of Topical Analgesia 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.

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Key information

Conditions

Pain, Acute Acute Pain Laceration Lacerations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Universitaire Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine-Prilocaine Cream 2.5-2.5%

Drug

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

Lidocaine 1% Epinephrine 0.005mg/mL solution

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Collaborators

  • University Hospital, Angers

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 7, 2017
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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