Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Mr Joao Paulo Goncalves dos Santos
ORCID ID
http://orcid.org/0000-0002-1086-9872
Contact details
Rua Da Constituinte
122/111
São Paulo
04204030
Brazil
+55 (0)11977297928
jpgdsantos@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
64900217.0.0000.5488
Study information
Scientific title
Lidocaine 5% patch application in painful surgical scars: a randomised controlled trial
Acronym
Study hypothesis
The lidocaine 5% patch is a useful tool for relieving post-operatory pain in patients who underwent foot and ankle surgeries.
Ethics approval
Ethics in Research Committee at Hospital Ipiranga - State Secretary of Health in São Paulo State, Brazil, 08/03/2017, ref: 1.953.666
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/12/2016
Overall trial end date
22/09/2017
Reason abandoned
Eligibility
Participant 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
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
01/04/2017
Recruitment end date
30/06/2017
Locations
Countries of recruitment
Brazil
Trial participating centre
Hospital Ipiranga
Avenida Nazaré, 28 - Ipiranga
São Paulo
04262-000
Brazil
Sponsor information
Organisation
Hospital Ipiranga
Sponsor details
Avenida Nazaré
28 - Ipiranga
São Paulo
04262000
Brazil
+55 (0)1120677799
rob.ike@hotmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication in Acta Ortopedica Brasileira, a Brazilian orthopedic journal.
IPD sharing statement
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).
Intention to publish date
01/12/2017
Participant level data
Available on request
Results - basic reporting
Publication summary