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
| ISRCTN | ISRCTN68691928 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68691928 |
| EudraCT/CTIS number | 2007-000619-27 |
| Secondary identifying numbers | 56481676 |
- Submission date
- 29/05/2007
- Registration date
- 16/07/2007
- Last edited
- 13/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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 6 months. 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
Contact information
Scientific
University Hospitals of Leicester NHS Trust
Department of Anaesthesia Critical Care and Pain Management
Victoria Building
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
| Phone | +44 (0)116 258 5291 |
|---|---|
| jt23@le.ac.uk |
Study information
| Study design | Randomised placebo-controlled double-blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 objectives | 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(s) | Trent Research Ethics Committee, 13/08/2007, ref: 07/H0405/42 |
| Health condition(s) or problem(s) studied | Lower limb amputation |
| Intervention | Perineural infusion of levobupivacaine 1.25 mg/ml versus placebo for 96 hours after surgery. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levobupivacaine |
| Primary outcome measure | Current primary outcome measure as of 15/09/2021: Late stump pain, phantom limb sensations and phantom limb pain up at 6 months after surgery. Previous primary outcome measure: Late stump pain, phantom limb sensations and phantom limb pain up to one year after surgery. |
| Secondary outcome measures | Current secondary outcome measures as of 15/09/2021: The following will be measured at 6 weeks, 3 months, and 6 months after surgery: 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) Previous 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 up to 12 months after surgery. |
| Overall study start date | 01/07/2007 |
| Completion date | 03/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 132 |
| Total final enrolment | 90 |
| Key inclusion criteria | Patients admitted to our vascular unit requiring a below or above knee amputation irrespective of aetiology. |
| Key exclusion criteria | Current exclusion criteria as of 24/08/2021: 1. Patients not considered for surgical intervention 2. Patients who are deemed unfit to undergo surgery under general anaesthesia 3. Patients undergoing surgery under regional anaesthesia 4. Patients unable to operate a Patient-Controlled Analgesia (PCA) device or cooperate with evaluation of pain scores e.g. those with confusional states 5. Patients unwilling to consent 6. Allergy to any study medication _____ Previous 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 |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 03/10/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
LE1 5WW
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Professor David Rowbotham
Research Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 116 258 4199 |
|---|---|
| djr8@le.ac.uk | |
| Website | http://www.uhl-tr.nhs.uk/ |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Presentations at scientific meetings and planned publication in a high impact peer reviewed journal. Data presented in part at BJA Research Forum, December 2019 and published in abstract form in the British Journal of Anaesthesia April 2020 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 01/04/2020 | 24/08/2021 | No | No | |
| Basic results | 24/08/2021 | 24/08/2021 | No | No | |
| Results article | 01/04/2020 | 24/08/2021 | Yes | No | |
| Results article | 10/02/2023 | 13/02/2023 | Yes | No |
Additional files
Editorial Notes
13/02/2023: Publication reference added.
15/09/2021: The following changes have been made:
1. The primary outcome measure has been updated.
2. The secondary outcome measures have been updated.
3. The EudraCT number has been added.
4. The plain English summary has been updated to reflect the changes above.
24/08/2021: The following changes were made to the trial record:
1. The basic results have been uploaded as an additional file.
2. Publication references added.
3. The total final enrolment was added.
4. The exclusion criteria were changed.
5. The recruitment end date was changed from 31/12/2012 to 03/10/2013.
6. The publication and dissemination plan was added.
7. The participant level data was changed from "Not provided at time of registration" to "Available on request"
8. The overall end date was changed from 31/12/2012 to 03/10/2012.
9. The target number of participants, was changed from 62 to 132.
09/08/2017: No publications found in PubMed, verifying study status with principal investigator.
