The use of local anesthetics in wounds
| ISRCTN | ISRCTN14408476 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14408476 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 14/03/2015
- Registration date
- 26/03/2015
- Last edited
- 29/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Anaesthesia with topical lidocaine hydrochloride gauzes in acute traumatic wounds: an observational study |
| Study acronym | LIGA Study (Lidocaine Impregnated Gauzes in Acute wounds) |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lidocaine hydrochloride 2% |
| Primary outcome measure | 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 study start date | 01/10/2014 |
| Completion date | 01/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Convenience sample during 8 weeks |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/10/2014 |
| Date of final enrolment | 01/12/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amsterdam
1105 AZ
Netherlands
Sponsor information
Hospital/treatment centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | One article with the main results will be submitted to a medical peer reviewed journal |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2016 | Yes | No |
Editorial Notes
29/01/2019: Publication reference added.
