Condition category
Musculoskeletal Diseases
Date applied
08/05/2014
Date assigned
02/07/2014
Last edited
02/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Conditions such as diabetes and vascular disease can lead to a reduction of blood supply to one or more limbs, such as a leg. In the worst cases, this can result in gangrene and the affected limb has to be removed (amputated). People who have had a leg amputated often experience what is called phantom pain, where they feel pain from the limb that is no longer there. Phantom pain is a very real phenomenon and can have a damaging effect on a person’s well-being and quality of life. It is currently treated using conventional pain killers or by an epidural (EDA - where anaesthetic is injected into the lower back to numb the nerves) but, to date, there is no really effective way to treat the condition. Peripheral nerve blocks (PNB) are often successfully used to relieve pain for people undergoing hip surgery. They work by blocking the pain signals from a nerve to the brain by injecting the area surrounding the nerve with a local anaesthetic. This study will compare the effect of PNB and EDA when used for the treatment of phantom pain.

Who can participate?
Adults aged 65 or older undergoing amputation of one or both legs.

What does the study involve?
Patients are randomly allocated to one of two groups: the intervention group or the control group. The intervention group receives PNB via a thin tube inserted at the back of the knee, whereas the control group receive EDA (usual care). Assessments will focus on phantom pain, phantom sensation and overall wellbeing/quality of life during their stay in the hospital and at 3, 6 and 12 months after surgery.

What are the possible benefits and risks of participating?
We believe that PNB can improve patients’ well-being and that this pain relief method can provide a secure and durable pain relief. Pain management during and after surgery might shorten the time of immobilization and reduce the risk of other complications.

Where is the study run from?
This study will be conducted in Norrland University Hospital (Sweden).

When is the study starting and how long is it expected to run for?
The study started in May 2014 and will run for 2 years.

Who is funding the study?
1. County Council of Västerbotten (Sweden)
2. Dementia Foundation (Sweden)

Who is the main contact?
Miss Anna Unneby
unneby85@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Miss Anna Unneby

ORCID ID

Contact details

Umeå University Hospital
Department of Orthopedics
Umeå
901 85
Sweden
unneby85@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Could treatment with prolonged peripheral nerve block reduce phantom limb pain on lower extremity amputation? A randomized controlled study

Acronym

AMP-study

Study hypothesis

Patients who undergo lower leg amputation have less postoperative pain and reduced incidence of phantom pain with long-term treatment with intermittent peripheral nerve block compared with conventional pain management.

Ethics approval

Ethical Committee of the Faculty of Medicine at Umeå University, 23/01/2014, ref: 2013-413-31M

Study design

Randomized 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 below to request a patient information sheet

Condition

Transtibial amputation of one or both legs, phantom limb pain

Intervention

Once the doctor has decided on amputation he/she will contact the research nurse, which in turn will provide written and verbal information about the study to the patient for approval of participation. Then the patient is randomized to a treatment group by drawing lots. A non-transparent envelope is opened containing information about the study and consent forms to be signed. A person who is not included in the study mixes the envelopes with the two treatment options, then placed them in a single junction of the department where the study will be conducted. The person who gives the information to the patient takes the top envelope in the pile.

1. The intervention group receives a peripheral nerve block of the ischiadic nerve by placing a catheter just above the back of the knee using ultrasound adjacent with the ischiadic nerve. This is done in conjunction with the amputation. Postoperatively local anesthetic of Chirocaine 2.5 mg / ml, 20 ml is administered as bolus into the catheter at intervals of 4-6 hours/day. Treatment with peripheral nerve blockade continues until the patient is discharged.
2. The control group receive EDA (epidural) pain management which is currently the usual pain treatment for amputations.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Phantom pain
2. Phantom sensation
Measured from the day of surgery (six times a day, for at least 1 week), from day 7 until discharge 3 times a day and at 3, 6 and 12 months.

Secondary outcome measures

1. Quality of life
2. Subjected well-being [Philadelphia Geriatric Center Morale Scale (PGCMS)]
3. Depression [15-item Geriatric Depression Scale (GDS-15)]
Measured from the day of surgery (six times a day, for at least 1 week), from day 7 until discharge 3 times a day and at 3, 6 and 12 months.

Overall trial start date

19/05/2014

Overall trial end date

31/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 65 years or older
2. With a decision from the responsible orthopedic physician that a transtibial amputation of one or both legs is necessary
3. Residents to the county of Norrland University Hospital

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

60

Participant exclusion criteria

Younger than age 65

Recruitment start date

19/05/2014

Recruitment end date

31/05/2016

Locations

Countries of recruitment

Sweden

Trial participating centre

Umeå University Hospital
Umeå
901 85
Sweden

Sponsor information

Organisation

County Council of Västerbotten (Sweden)

Sponsor details

Umeå University Hospital
Umeå
901 85
Sweden

Sponsor type

Government

Website

http://www.vll.se/default.aspx?id=23095&refid=23096

Funders

Funder type

Government

Funder name

County Council of Västerbotten (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dementia Foundation (Sweden)

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