Condition category
Surgery
Date applied
08/11/2017
Date assigned
09/11/2017
Last edited
09/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes