Condition category
Signs and Symptoms
Date applied
14/08/2014
Date assigned
03/09/2014
Last edited
19/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes