Plain English Summary
Background and study aims
Artherosclerosis is a serious condition where the blood vessels (arteries) get blocked by fatty substances. This study is looking at treatment of pain after thigh amputation. The aim is to find out whether a local anesthetic ropivacain given for three days reduces pain after amputation in patients with atherosclerosis.
Who can participate?
Patients who are undergoing above knee amputation as a result of artherosclerosis.
What does the study involve?
The patients are randomly allocated to one of two groups. Each group receives a single dose of local anesthetic or dummy (saline) for three days after the operation. Patients will verbally rate the level of pain. The patients will also receive paracetamol and opioid for the treatment of pain. The patients are contacted 1, 3 and 12 months after the operation.
What are the possible benefits and risks of participating?
The benefit of the study is efficient pain treatment, especially for patients in the future. The risks of the study are minor, as the technique has been used for several years and the local anesthetic is well tolerated.
Where is the study run from?
The study is carried out in eight centers in Finland. The main center is Helsinki University Hospital- Jorvi Hospital , and the other centers are Meilahti Hospital in Helsinki, Turku University Hospital, Oulu University Hospital, Kuopio University Hospital, Tampere University Hospital, Lahti Central Hospital and Jyvaskyla Central Hospital.
When is the study starting and how long is it expected to run for?
It will start on September 2014. The patients will be recruited for two years and will be followed up for 12 months after operation. The last month of recruitment would be September 2016, and the follow up would last until September 2017.
Who is funding the study?
The study is funded by Helsinki University Hospital, Finland.
Who is the main contact?
Dr Hanna von Plato
Tel +350 50 428 44 71
Trial website
Contact information
Type
Scientific
Primary contact
Dr Vesa Kontinen
ORCID ID
Contact details
HUS Jorvin sairaala
Espoo
00029 HUS
Finland
-
vesa.kontinen@helsinki.fi
Additional identifiers
EudraCT number
2013-003807-20
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Peripheral local anesthetic infusion for postoperative pain after above knee amputation
Acronym
FinAPain-1
Study hypothesis
Continuous infusion of local anesthetic will reduce pain after above knee amputation.
Ethics approval
HUS Operative Ethics Commitee (HUS Operatiivinen eettinen toimikunta); 11/12/2013
Study design
Randomised controlled double-blind study
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 below to request a patient information sheet
Condition
Pain after amputation above knee
Intervention
Continuous peripheral infusion of local anesthetic ropivacaine for 72 hours through two catheters, placed in the sciathic nerve sheath and under the amputation wound. The randomisation was done with computer-generated randomisation list on random.org, in blocks of ten patients. It was done by a person who is not working with the study otherwise. The follow-up is done by a study nurse who contacts the patients by a telephone call on 1, 3 and 12 months after the operation.
Intervention type
Drug
Phase
Not Applicable
Drug names
Ropivacaine
Primary outcome measure
Pain on the amputated limb 1-5 days after the operation assessed on VRS 0-4.
Secondary outcome measures
1. Pain on the amputated limb 1,3 and 12 months after the operation and amputation phantom limb pain 1-5 days after the operation and 1, 3 and 12 months after the operation on VRS 0-4
2. The consumption of opioid 1-5 days after the operation
3. Adverse events
Overall trial start date
01/09/2014
Overall trial end date
01/09/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients presenting for above knee amputation for atherosclerosis obliterans willing to participate
2. Able to give informed consent
3. Able to assess pain using a verbal rating scale
4. Assesssed to be medically stable so that life expectancy exceeds 2 weeks as assessed by recruiting anesthesiologist
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180
Participant exclusion criteria
1. Allergy to amide local anesthetics
2. Operating surgeon unable to insert the catheter as defined in the protocol
3. Planned epidural postoperative pain management
Recruitment start date
01/09/2014
Recruitment end date
01/09/2016
Locations
Countries of recruitment
Finland
Trial participating centre
HUS Jorvin sairaala
Espoo
00029 HUS
Finland
Sponsor information
Organisation
Helsinki University Hospital (Finland)
Sponsor details
c/o Hanna von Plato
Acute pain study group
HUS Jorvin sairaala
Espoo
00029 HUS
Finland
-
hanna.von.plato@hus.fi
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Helsinki University Hospital (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list