Condition category
Injury, Occupational Diseases, Poisoning
Date applied
14/03/2015
Date assigned
26/03/2015
Last edited
13/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In the emergency department (ED) pain treatment in acute wounds is often accomplished by injection with a local anesthetic (LA), for example lidocaine. As this can be painful, topical application (application to the surface of the skin) could be a painless alternative. Several studies have already investigated commercially available preparations for this purpose, however, it is not known whether the use of lidocaine without any additives, such as adrenaline (to locally constrict the blood vessels) works to treat pain in wounds requiring wound treatment. The aim of this study is to investigate whether lidocaine hydrochloride soaked gauzes can be successfully used to provide pain relief in treatment of acute traumatic wounds.

Who can participate?
Adults (at least 18) presenting in the emergency department with an acute wound.

What does the study involve?
Patients with acute traumatic wounds presenting to the ED treated with a nursing protocol using lidocaine soaked gauzes are included in the study and are asked about their experiences regarding pain in the period before and during wound treatment.

What are the possible benefits and risks of participating?
Benefits are that there will be more attention to the pain experienced by the patient. There are no risks involved besides the use of lidocaine gauzes, as this is standard practice.

Where is the study run from?
Academic Medical Center, Amsterdam (Netherlands)

When is the study starting and how long is it expected to run for?
October 2014 to December 2014

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Milan Ridderikhof

Trial website

Contact information

Type

Scientific

Primary contact

Dr Milan Ridderikhof

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Anaesthesia with topical lidocaine hydrochloride gauzes in acute traumatic wounds: an observational study

Acronym

LIGA Study (Lidocaine Impregnated Gauzes in Acute wounds)

Study hypothesis

Lidocaine hydrochloride 2% soaked gauzes can effectively be used in providing analgesia in treatment of acute traumatic wounds in adult patients in the ED

Ethics approval

Waiver number W14_311#14.17.0374

As the study was purely an observational study (there was already a nursing protocol in use describing the use of lidocaine gauzes in acute wounds) the IRB decided the Medical Research Involving Human Subjects Act did not apply to the study protocol

Study design

Observational case series in a single-center (in which a nursing protocol using lidocaine soaked gauzes is already in place)

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Adult patients with acute traumatic wounds presenting to the ED

Intervention

Application of lidocaine hydrochloride (2%) soaked gauze in the wound before wound treatment

Intervention type

Drug

Phase

Not Applicable

Drug names

Lidocaine hydrochloride 2%

Primary outcome measures

Need for additional infiltration anaesthesia: this was measured at moment of surgical wound treatment at the ED.

Secondary outcome measures

1. NRS pain scores measured just before surgical wound treatment and during surgical wound treatment (in case no additional infiltration anaesthesia was required)
2. Adverse events: measured during the complete ED presentation
3. Satisfaction: measured at the end of wound treatment

Overall trial start date

01/10/2014

Overall trial end date

01/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years and older
2. Presentation to the ED with an acute traumatic wound
3. Received analgesic treatment with lidocaine soaked gauzes (according to nursing protocol)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Convenience sample during 8 weeks

Participant exclusion criteria

1. Age 80 years and older
2. Body weight < 50 kg
3. Known allergy for local anaesthetics
4. Clinical suspicion of nerve injury
5. Manchester Triage System (MTS) category orange or red
6. Wounds due to chemical or thermal injury

Recruitment start date

01/10/2014

Recruitment end date

01/12/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (Academisch Medisch Centrum)
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center (Academisch Medisch Centrum)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

One article with the main results will be submitted to a medical peer reviewed journal

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes