Lidocaine patch application in painful surgical scars
| ISRCTN | ISRCTN59332544 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59332544 |
| Secondary identifying numbers | 64900217.0.0000.5488 |
- Submission date
- 08/11/2017
- Registration date
- 09/11/2017
- Last edited
- 01/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Chronic (long-term) pain after surgery is a frequent complaint in orthopedic practice. Drug and non-drug treatments have been proposed for this condition. Recently, a lidocaine (local anesthetic) patch has been developed. The aim of this study is to test this plaster as a method of treatment for pain after orthopedic surgery in comparison to therapeutic massage performed on the incision.
Who can participate?
Patients between 13 and 70 years old who underwent foot and ankle surgery and experience pain at least 3 months later
What does the study involve?
Patients are randomly allocated to one of two groups. One group apply the lidocaine patch for 12 hours a day for 3 months. The other group perform manual manoeuvres over the scar for 10 minutes each, 3 times a day, over 3 months. Pain, satisfaction with the surgery and quality of life are assessed at the start of treatment and after 30, 60 and 90 days.
What are the possible benefits and risks of participating?
Participants could benefit from pain relief and improved quality of life. The risks include drug hypersensitivity and overdose.
Where is the study run from?
Hospital Ipiranga (Brazil)
When is the study starting and how long is it expected to run for?
December 2016 to September 2017
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Joao Paulo Gonçalves dos Santos
jpgdsantos@gmail.com
Contact information
Public
Rua Da Constituinte, 122/111
São Paulo
04204030
Brazil
 ORCID ID |
0000-0002-1086-9872 |
|---|---|
| Phone | +55 (0)11977297928 |
| jpgdsantos@gmail.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Lidocaine 5% patch application in painful surgical scars: a randomised controlled trial |
| Study objectives | The lidocaine 5% patch is a useful tool for relieving post-operatory pain in patients who underwent foot and ankle surgeries. |
| Ethics approval(s) | Ethics in Research Committee at Hospital Ipiranga - State Secretary of Health in São Paulo State, Brazil, 08/03/2017, ref: 1.953.666 |
| Health condition(s) or problem(s) studied | Post-operative pain |
| Intervention | Patients are randomised using random.org to either: 1. Application of lidocaine 5% patch for 12 hours/day for 3 months 2. Manual maneuvers over the scar for 10 minutes each, 3 times a day, over 3 months |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain, measured with the visual analogue scale (VAS) at baseline and 30, 60 and 90 days of follow-up |
| Secondary outcome measures | Measured at baseline and 30, 60 and 90 days of follow-up: 1. Satisfaction with surgery, measured with the personal satisfaction index 2. Quality of life, measured with the SF-36 questionnaire |
| Overall study start date | 01/12/2016 |
| Completion date | 22/09/2017 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 37 |
| Key inclusion criteria | 1. Patients between 13 and 70 years old 2. Underwent foot and ankle surgery at Hospital Ipiranga between January 2015 and February 2017 3. Sustained post-operative pain at least 3 months after the procedure |
| Key exclusion criteria | 1. Patients younger than 13 and older than 70 years old 2. Allergics to lidocaine 3. Skin lesions or illness 4. Non-union or malunion 5. Infection 6. Patients who abandon follow-up |
| Date of first enrolment | 01/04/2017 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- Brazil
Study participating centre
São Paulo
04262-000
Brazil
Sponsor information
Hospital/treatment centre
Avenida Nazaré, 28 - Ipiranga
São Paulo
04262000
Brazil
| Phone | +55 (0)1120677799 |
|---|---|
| rob.ike@hotmail.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in Acta Ortopedica Brasileira, a Brazilian orthopedic journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from João Paulo Gonçalves dos Santos (jpgdsantos@gmail.com) or Rafael da Rocha Macedo (rrochamacedo@yahoo.com.br). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/10/2021 | 01/12/2022 | Yes | No |
Editorial Notes
01/12/2022: Publication reference and total final enrolment added.
