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

ISRCTN ISRCTN23704397
DOI https://doi.org/10.1186/ISRCTN23704397
Secondary identifying numbers N/A
Submission date
08/05/2014
Registration date
02/07/2014
Last edited
24/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Miss Anna Unneby
Scientific

Umeå University Hospital
Department of Orthopedics
Umeå
901 85
Sweden

Email unneby85@gmail.com

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCould treatment with prolonged peripheral nerve block reduce phantom limb pain on lower extremity amputation? A randomized controlled study
Study acronymAMP-study
Study objectivesPatients 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(s)Ethical Committee of the Faculty of Medicine at Umeå University, 23/01/2014, ref: 2013-413-31M
Health condition(s) or problem(s) studiedTranstibial amputation of one or both legs, phantom limb pain
InterventionOnce 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date19/05/2014
Completion date01/06/2017

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants60
Key inclusion criteria1. 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
Key exclusion criteriaYounger than age 65
Date of first enrolment19/05/2014
Date of final enrolment31/05/2016

Locations

Countries of recruitment

  • Sweden

Study participating centre

Umeå University Hospital
Umeå
901 85
Sweden

Sponsor information

County Council of Västerbotten (Sweden)
Government

Umeå University Hospital
Umeå
901 85
Sweden

Website http://www.vll.se/default.aspx?id=23095&refid=23096
ROR logo "ROR" https://ror.org/04xvhsp09

Funders

Funder type

Government

County Council of Västerbotten (Sweden)

No information available

Dementia Foundation (Sweden)

No information available

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

24/01/2019: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 31/05/2016 to 01/06/2017
2. The intention to publish date has been added