Continuous administration of local anesthetic for pain after amputation above knee

ISRCTN	ISRCTN45530042
DOI	https://doi.org/10.1186/ISRCTN45530042
EudraCT/CTIS number	2013-003807-20
Secondary identifying numbers	N/A

Submission date: 14/08/2014
Registration date: 03/09/2014
Last edited: 19/06/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Vesa Kontinen
Scientific

HUS Jorvin sairaala
Espoo
00029 HUS
Finland

Email	vesa.kontinen@helsinki.fi

Study information

Study design	Randomised controlled double-blind study
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 below to request a patient information sheet
Scientific title	Peripheral local anesthetic infusion for postoperative pain after above knee amputation
Study acronym	FinAPain-1
Study objectives	Continuous infusion of local anesthetic will reduce pain after above knee amputation.
Ethics approval(s)	HUS Operative Ethics Commitee (HUS Operatiivinen eettinen toimikunta); 11/12/2013
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/09/2014
Completion date	01/09/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	180
Key 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
Key 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
Date of first enrolment	01/09/2014
Date of final enrolment	01/09/2016

Locations

Countries of recruitment

Finland

Study participating centre

HUS Jorvin sairaala

Espoo
00029 HUS
Finland

Sponsor information

Helsinki University Hospital (Finland)
Hospital/treatment centre

c/o Hanna von Plato
Acute pain study group
HUS Jorvin sairaala
Espoo
00029 HUS
Finland

Email	hanna.von.plato@hus.fi
"ROR"	https://ror.org/02e8hzf44

Funders

Funder type

Hospital/treatment centre

Helsinki University Hospital (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan