Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
An amputation is the surgical removal of part of the body, such as an arm or leg. In the UK, about 5000 people each year have their leg amputated. Patients usually have a long hospital stay, require long-term rehabilitation and frequently need institutional support on leaving hospital. After surgery, patients may experience severe pain as well as phantom pain and phantom sensations. So-called ‘stump pain’ comes from the wound site itself. Although a good recovery is possible after amputation, pain complicates rehabilitation, making it more difficult to use prosthetic limbs and regain mobility, limiting independence and the ability to work. Chronic pain can also cause depression, sleep deprivation, a reluctance to socialise, and difficulties with everyday activities. Phantom limb pain is particularly difficult to treat, with many sufferers relying on strong painkillers such as morphine. These are not always successful and often cause significant side effects. We are performing a study of a new technique to find out how it affects pain after amputation.

Who can participate?
Patients requiring a below or above knee amputation because of vascular (blood vessel) disease.

What does the study involve?
The new technique involves placing a small tube, called a catheter, directly into the major nerve of the leg (the sciatic nerve) at the time of surgery and infusing a local anaesthetic called levobupivacaine for 4 days. The research team are assessing the effects of this new treatment on pain early after surgery, and the incidence and severity of phantom limb over the following year. The team are also assessing the long-term physical and psychological effects on mood, physical disability and quality of life.

What are the possible benefits and risks of participating?
The researchers believe the new technique that they are investigating has the potential to relieve pain, aid rehabilitation and improve quality of life for people who have had their leg amputated because of vascular disease. This study will reveal whether their technique does give these benefits. If proved effective, it is possible this technique could also be used in people who are undergoing amputations for other reasons, for example severe traumatic injuries or bone cancer. An effective treatment that relieves pain could make a real difference to people who have had their leg amputated. Coping with pain can be exhausting. Freedom from pain could reduce people’s reliance on painkillers and hugely improve their well-being and quality of life. Freedom from pain after surgery could boost patients’ chances of making a good recovery and reduce the time spent in hospital. It could help patients use prosthetic limbs more successfully, improve mobility and aid rehabilitation. These factors contribute to providing patients with greater potential for living independently after surgery and of returning to work. In addition, the increased independence and improved body image that come with successful rehabilitation can significantly boost people’s self-esteem. There are no specific risks to taking part in the study but patients are attached to a small infusion device for 4 days after surgery.

Where is the study run from?
Leicester Royal Infirmary (UK).

When is the study starting and how long is it expected to run for?
From July 2007 to December 2012.

Who is funding the study?
Action Medical Research (UK).

Who is the main contact?
Dr Jonathan Thompson

Trial website

Contact information



Primary contact

Dr Jonathan Thompson


Contact details

University Hospitals of Leicester NHS Trust
Department of Anaesthesia Critical Care and Pain Management
Victoria Building
Leicester Royal Infirmary
United Kingdom
+44 (0)116 258 5291

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Prospective, double-blind, randomised trial to assess the efficacy of continuous sciatic/posterior tibial nerve blockade via a neural sheath catheter in lower limb amputees


Study hypothesis

That continuous neural sheath infusion of levobupivacaine after major lower limb amputation will reduce the incidence of late phantom pain/phantom limb sensations and stump pain.

On 16/10/2012 the overall trial end date was changed from 01/01/2010 to 31/12/2012.

Ethics approval

Trent Research Ethics Committee, 13/08/2007, ref: 07/H0405/42

Study design

Randomised placebo-controlled double-blind study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Lower limb amputation


Perineural infusion of levobupivacaine 1.25 mg/ml versus placebo for 96 hours after surgery.

Intervention type



Not Applicable

Drug names


Primary outcome measures

Late stump pain, phantom limb sensations and phantom limb pain up to one year after surgery.

Secondary outcome measures

1. Early postoperative pain and morphine requirements
2. Late effects on mood, physical disability and quality of life, measured using the Late Life disability index (quality of life and disability), the 36-item Short Form health survey (SF-36) inventory, (pain and disability) the McGill pain questionnaire (pain) and the University of Leicester Amputee questionnaire (pain and disability)

Secondary outcomes will be measured at 6 weeks, 3, 6 and 12 months after surgery.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Patients admitted to our vascular unit requiring a below or above knee amputation irrespective of aetiology.

Participant type


Age group

Not Specified



Target number of participants


Participant exclusion criteria

1. Patients not considered for surgical intervention
2. Patients who are deemed unfit to undergo surgery under general anaesthesia
3. Patients unable to operate a Patient-Controlled Analgesia (PCA) device or cooperate with evaluation of pain scores e.g. those with confusional states
4. Patients unwilling to consent
5. Allergy to any study medication

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester NHS Trust
United Kingdom

Sponsor information


University Hospitals of Leicester NHS Trust (UK)

Sponsor details

c/o Professor David Rowbotham
Research Office
Leicester General Hospital
Gwendolen Road
United Kingdom
+44 (0)116 258 4199

Sponsor type




Funder type

Research organisation

Funder name

Association of Anaesthetists of Great Britain and Ireland (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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