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
+44 116 258 4199
djr8@le.ac.uk
Sponsor type
Government
Website
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