Condition category
Surgery
Date applied
29/05/2007
Date assigned
16/07/2007
Last edited
13/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
jt23@le.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonathan Thompson

ORCID ID

Contact details

University Hospitals of Leicester NHS Trust
Department of Anaesthesia Critical Care and Pain Management
Victoria Building
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
+44 (0)116 258 5291
jt23@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

56481676

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Lower limb amputation

Intervention

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

Intervention type

Drug

Phase

Not Applicable

Drug names

Levobupivacaine

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

01/07/2007

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

62

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

01/07/2007

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester NHS Trust
Leicester
LE1 5WW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

c/o Professor David Rowbotham
Research Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0)116 258 4199
djr8@le.ac.uk

Sponsor type

Government

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Research organisation

Funder name

Association of Anaesthetists of Great Britain and Ireland (UK)

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